October 2009

 A symposium, “Approaches to Safe Nanotechnology: A Global Perspective,” was held at the XVIII World Congress on Safety and Health at Work in Seoul, Korea.  That brought together speakers/scientists from seven countries to discuss the topic, including those from the United States, Japan, Korea, Australia, Germany, France, and Italy.  The lessons learned and the importance of global collaboration on nanotechnology safety and health research were discussed.  A report of the symposium proceedings was recently published by the United States participant, the National Institute for Occupational Safety and Health (NIOSH), “A Global Perspective on Safe Nanotechnology,” NIOSH Publication No. 2009-130. read more

A new study published October 25, 2009, in Nature Nanotechnology online --  "Inhaled Carbon Nanotubes Reach the Subpleural Tissue in Mice" --  provides further evidence for the asbestos-like effects of certain types of carbon nanotubes.

The study, by researchers at North Carolina State University, The Hamner Institutes for Health Sciences, and the National Institute of Environmental Health Sciences (all in the United States), found for the first time that multi-walled carbon nanotubes (MWCNTs) reach the outer lining of the lung when inhaled - as asbestos does.  The findings raise concerns that inhaled nanotubes may cause pleural fibrosis and/or mesothelioma.

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The top 10 Pharma companies (alphabetically Abbott, AstraZeneca, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis) all have significant nanotechnology-related programs.   Here are some additional facts of interest. 
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An October 21, 2009, paper by Germany's Federal Environment Agency (Umweltbundesamt, UBA) triggered fearful headlines in some of the country's biggest newspapers and in the blogosphere:

"German Environment Agency: Don’t use nano-materials!”

“Nanotechnology can make you sick”

“The German Environment Agency warns against nanotechnology”

The paper, "Nanotechnology for Humans and the Environment: Increasing Chances, Minimizing Risks," certainly expresses reservations about nanotechnology. For example, the UBA calls for a register of nanotechnology products and consumer product labeling indicating that a product contains nano-particles. But the paper is cautious in its criticism and certainly not anything close to the near hysteria expressed by some respectable German newspapers and others that have picked up those stories.

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An article by Reed D. Rubinstein of Greenberg Traurig LLP, in the new issue of Nanotechnology Law & Business (Fall 2009), discusses a “petition” filed with the United States Environmental Protection Agency (EPA) by the International Center for Technology Assessment (ICTA) and other special interest groups. The Petition claims that “research has mounted to indicate that nano-silver materials pose serious risks to human health and the environment.” As a result, the Petition demands (among other things) that the EPA regulate all nano-silver products as pesticides, and stop the use or sale of all consumer products using nano-silver under the authority of FIFRA, the Federal Insecticide, Fungicide and Rodenticide Act. read more

Concerns have been raised about whether workers exposed to engineered nanoparticles are at increased risk of adverse health effects. The current body of evidence about the possible health risks of occupational exposures to engineered nanoparticles is quite small, and uncertainty means risk.

A new Canadian study to appear in a forthcoming issue of the International Journal of Nanotechnology suggests that current protective equipment used for existing chemicals may not offer adequate protection for workers handling nanomaterials. The study, by engineers in the Department of Mechanical Engineering at Montreal’s School of Higher Technology, suggests that urgent research is necessary into the risks associated with the growing field of nanotechnology manufacture so that appropriate protective equipment can be developed. Prevention of harmful exposures from ingestion, inhalation, and dermal absorption are the reason that protective clothing and gloves, in addition to respirators, are often an essential and common sight in the chemical industry. However, the Canadian researchers wonder if standard protection against chemical risks is enough for workers who are handling nanomaterials. read more

On October 5, 2009, the Wisconsin Department of Natural Resources hosted a roundtable discussion with Dr. Andrew Maynard, Chief Science Advisor, Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars in Washington, D.C.

Discussion topics include nanotechnology basics and definitions, manufacturing process and opportunities, regulatory status, and potential environmental and health concerns.
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In a 10/12/09 post with the above-title, GreenFudge.org poses the important question, which has no clear answer:  "So what’s so scary about nanotechnology?"

With technological progress comes the increased potential for misuse and harm. The post suggests that fears about nanotechnology include those imagined (for example, tiny machines let loose into the environment; self-replicating nanobots that could conceivably become corrupt or out of control and act in a similar way that cancer cells – biological cells gone awry – do in organic bodies) and perhaps more realistic (imagine powerful nanotech in the wrong hands; dangerous nanoparticles being released into food and water sources by terrorists). And the fact that we simply still don’t know what nanotech is capable of, just as we used to be unaware that certain chemicals are poisonous or harmful to the environment or that CFCs were cutting a hole in the ozone layer.

Of course it is the latter type of fear that is of greatest practical significance to those companies involved with the manufacture and disrtibution of nanotechnology-enabled products, along with those in the risk management chain and their counsel.

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The Research Triangle Environmental Health Collaborative (The Collaborative) will gather 150 experts from around the nation at its second annual environmental health summit on October 8-9, 2009. The 2009 summit, “Environmentally Responsible Development of Nanotechnology,” is being held at the North Carolina Biotechnology Center in North Carolina’s Research Triangle Park.

This year’s summit features a broad and experienced group of participants representing wide areas of expertise and diverse views from Federal, State, and local governments; academia, industry, and public interest organizations. Speakers include Mark Wiesner, of Duke University’s Center for the Environmental Implications of NanoTechnology (CEINT), and Chad Holliday, Chairman of the Board and former CEO of DuPont, Inc.
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The FDA has thus far been relatively unconcerned about any unique safety issues of nanoscale products under its auspices, and believes that existing standards for safety and efficacy will be adequate for most nanotechnology medical products.  The FDA’s Nanotechnology Task Force published its Report in July 2007 and did not suggest the need for any immediate nano-specific regulatory action, but did recognize that obvious knowledge gaps exist concerning new risks presented by nanomaterials.  The FDA's position has critics. 

It remains to be seen what additional internal processes or regulatory actions, if any, the FDA will pursue to address nanospecific product and safety issues. This is an evolving area of regulatory law and all pharmaceutical, medical device, and health care risk managers and their attorneys must stay closely attuned.

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The mission of the U.S. Food and Drug Administration is, in part, to ensure that the drugs, drug delivery systems, medical devices, vaccines, and other biologic products reaching the marketplace are safe and effective. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicine more effective and more affordable. The oncoming "Age of Nanotechnology" brings into sharp focus the tension between assuring that regulated products are safe and effective while at the same time ensuring that new and potentially life-saving treatments are made available to the public as quickly as possible.

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