Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

 On May 4, 2011, research institute RTI International will host a policy forum entitled, "Nanotechnology: The Huge Challenge of Regulating Tiny Technologies." The forum will be held at the National Press Club in Washington, DC, where experts will discuss the issues and concerns regarding the difficulties faced by agencies in drafting federal regulation and trying to keep pace with the rate of evolution in some areas in the field of nanotechnology. The forum will address regulations and public policies "needed to maximize the benefits of this emerging technology while minimizing the risks in order to encourage further development, scientific exploration, and responsible commercialization of this technology."

Participants include:

MODERATOR

James "Jim" Trainham, PhD, Vice President, Strategic Energy Programs, RTI International

SPEAKERS

Jim Alwood, Toxic Substances Control Act Nanotechnology Coordinator, U.S. Environmental Protection Agency

Cole Matson, PhD, Executive Director, Center for the Environmental Implications of NanoTechnology at Duke University

Michele Ostraat, PhD, Senior Director, Center for Aerosol and Nanomaterials Engineering, RTI International

Sally Tinkle, PhD, Deputy Director, National Nanotechnology Coordination Office

Please visit the forum's website for more information:

http://www.rti.org/page.cfm?objectid=4F1E41AF-5056-B100-31FE7BB610DB5A3C

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Kadmon Pharmaceuticals LLC ("Kadmon"), a biopharmaceutical company focused on developing medicines and therapies in the areas of oncology, infectious diseases, and immunology, has entered into an agreement with research and development company Nano Terra, Inc. ("Nano Terra"), whereby Kadmon would acquire Nano Terra's perpetual, worldwide exclusive licenses to three novel, clinical stage product candidates and rights to its drug discovery platform, Pharmacomer Technology. Although specific terms of the agreement were not disclosed, but the companies did note that the licenses for the product candidates and the Pharmacomer technology platform will be transferred to NT Life Sciences, a newly formed joint venture co-owned by the companies.

The product candidates and technology platform "focus on breakthroughs in the functionality of pharmaceuticals at the molecular level which enable the discovery of new, small molecule drugs optimized to meet the challenges of human physiology and to evade the early development challenges of traditional medicinal chemistry practices."

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The Nanodermatology Society ("NDA" or "the society"), an organization of doctors, scientists, and researchers, was founded with the mission to "promote a greater understanding of the scientific and medical aspects of nanotechnology in skin health and disease." The society recently addressed concerns about the use of nano materials to formulate nanoparticulate titanium dioxide and zinc for use in sunscreen. These ingredients are already common ingredients in sunscreens in their traditional forms. Upon a rigorous review of scientific literature and the latest safety data, the NDS reported in a position statement that the use of these nano materials in sunscreen was safe.  The statement noted that "[s]tudies of newer sunscreens [formulated with nanoparticles] show that they are either coated to minimize reactivity, clump in aggregates, or do not penetrate the skin." Other organizations have claimed that nano-based sunscreens are unsafe. NDS hopes that its position statement "[a]s the first of its kind to be released by a scientific society" will encourage more research in the nanotechnology arena.

The full text of the statement is available at www.nanodermsociety.org.

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 Archaeologists excavating 2400 year old tombs at a site in Turkey are adding something new to the tools of the trade. According to a recent article 

highly specialized powders consisting of nanoparticles will be applied to the rock surfaces in square-centimeter doses. The nanoparticles will be specially designed to be chemically compatible with the rocks and will be used to clean, restore and protect the surfaces of the rock tombs. “In this way, the tombs will be restored and protected.”

In a similar fashion nanofluids are being used to clean and preserve the surfaces of murals and frescoes at Mesoamerican sites. As Paolo Samori put it:

, 'this is a bright example of how nanoscience can be used effectively to solve a wide variety of open issues, even in unexpected applications such as the removal of harmful polymer coatings from the surface of works of art.'

'Conservation science is a relatively young subject,' Baglioni concludes, but 'the contribution that chemistry, physics and nanosciences in general can give to art conservation is huge'. 

Wonder if Indy will  trade in the whip and fedora for nanoparticles in the next movie?

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The NanoSafety Consortium for Carbon just submitted a proposed toxicity testing agreement to EPA under Section 4 of the Toxic Substances Control Act covering a range of nanoscale materials including multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene. 

Key elements for the curious:

• The chemical substances to be tested may include representative (i) purified multi-walled carbon nanotubes ranging from 4 to 600 nanometers in diameter and less than 30 micrometers in length; (ii) purified double-walled carbon nanotubes ranging from 1.5 to 4 nanometers in diameter and less than 5 micrometers in length; (iii) purified single-walled carbon nanotubes ranging from .7 to 2 nanometers in diameter and less than 30 micrometers in length; and (iv) purified graphene nanoplatelets in flake/sheet form ranging from .5 nanometers to 100 nanometers thick. All test materials will be purified by the National Institute of Standards and Technology to be at least 99 percent pure. Final test materials will be approved by the EPA and will be selected to adequately represent the constituency of the final signatories to the testing agreement.

• The characteristic for which testing will be conducted is subchronic inhalation toxicity in rodents, or such other toxicity testing as may be approved by EPA to achieve the intent and purpose of the testing agreement. As appropriate, consideration will be given to using in vivo instillation rather than inhalation test methods. Test data will be developed under standards based on TSCA test guidelines in 40 CFR parts 796, 797, and 798, Organization for Economic Cooperation and Development (OECD) test guidelines, or other suitable test methodologies.  Specifically, the signatories will conduct a 90 day inhalation toxicity study in rats with a post exposure observation period of up to 3 months, including broncholaveolar lavage fluid analysis (OPPTS 870.3465 or OECD 413), or such other testing as may be approved by the EPA to achieve the intent and purpose of the testing agreement. Testing guidelines will be modified to account for nanoscale properties of the materials being tested. Such modifications are subject to EPA approval and will be incorporated into the below-referenced study plan.

If EPA decides to pursue the proposed testing agreement, it will initiate a six-month negotiation and comment period which will open to the public pursuant to 40 C.F.R. § 790.28.

Stay tuned.

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