Denmark Publishes Literature Review for Seven Nanomaterials

Posted on August 30, 2011 by Lynn L. Bergeson

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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FDA Regulatory Science Plan Addresses Nanomaterials and Nanotechnology

Posted on August 23, 2011 by Lynn L. Bergeson

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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Presentations Available from US-EU Workshop: Bridging NanoEHS Research Efforts

Posted on August 10, 2011 by Lynn L. Bergeson

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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NANO Act Promotes Development and Responsible Stewardship of Nanotechnology

Posted on August 4, 2011 by Lynn L. Bergeson

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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IATP Criticizes Development of Nanotechnology Products Without Regulatory Oversight

Posted on August 2, 2011 by Lynn L. Bergeson

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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