New Edition of Nanotechnology Law Report

New Edition of Nanotechnology Law Report

Inside you will find:

  • EPA Considering New Approach to Nanoscale Materials Under TSCA
  • EPA May Issue Mandatory Data Collection Rule for Nanoscale Materials Under TSCA
  • EPA Takes Aim at Antimicrobial Products Under FIFRA
  • EPA Unveils New Principles for Chemical Management Reform
  • EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens
  • EPA Withdraws Carbon Nanotube SNURs
  • Press Release: New Contributing Editor for InterNano
  • Virginia CLE presentation: “Insurance, Nanotechnology, and Risk”
  • Nanoparticles and Deaths in the People’s Republic
  • Sweating the Small Stuff
  • Soil Association Cites China Deaths in Renewed Call for Moratorium on Nanotechnology Commercialization
  • Nanotechnology Legislation in the 111th Congress
  • Mapping Nano
  • Flight of the Nanobees

 

New National Nanomanufacturing Network Newsletter

The National Nanomanufacuring Network (NNN) at the University of Massachusetts, Amherst just published its October newsletter which you can find here.  There is a nice article by Barbara Beck and Chris Long from Gradient regarding the recent Song nanoparticle study from China which was my first contributing editor piece for NNN's InterNano.  Please read the newsletter and follow NNN's valuable work.

Study of Chinese Print Workers Claims to Provide the First Human Evidence of the Clinical Toxicity of Long-term Nanoparticle Exposures

This article was originally published by the National Nanomanufacturing Network's "InterNano" project (www.internano.com).  It is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

A recent study published in the well-known medical journal, the European Respiratory Journal, has been receiving significant publicity as the authors have claimed their findings support an apparent linkage between workplace exposures to nanoparticles and severe respiratory disease. Specifically, in this study, investigators at China's Capital University of Medical Science related unusual and progressive lung disease in seven Chinese workers, two of whom died, to nanoparticle exposures in a print plant where a polyacrylic ester paste containing nanoparticles was used. This linkage was made by the study investigators despite a general lack of exposure data for the workers. 
 

The complete review is after the jump . . .

Reviewed by Christopher M. Long, Sc.D., and Barbara D. Beck, Ph.D., DABT, FATS, Gradient

While there are cellular and laboratory animal studies that suggest the enhanced toxicity of some engineered nanoparticles (ENP) relative to larger sized particles of the same chemical composition (e.g., carbon nanotubes versus graphite, nano-sized titanium dioxide versus conventional titanium dioxide), there remains no direct human evidence of the health risks posed by ENP. The absence of any epidemiology or medical case studies examining potential ENP exposures and adverse health effects among either workers or consumers is likely a result of several factors. These factors include the fairly recent intensification in ENP manufacturing and commercial application, as well as the fact that relatively small amounts are typically manufactured and handled. The Song et al. (2009) study is a medical case report that claims to provide the first human evidence of "nanomaterial-related disease" following long-term nanoparticle exposure.

This study attributed unusual and progressive lung disease in seven Chinese workers, two of whom died of respiratory failure, to workplace nanoparticle exposures in a print plant where a polyacrylic ester paste containing nanoparticles was sprayed onto a polystyrene substrate, with subsequent heat-curing. For 5 to 13-month durations, all seven employees worked in the same department of the print plant, specifically, in a room with little to no ventilation due to the failure of the mechanical ventilation system. Lacking any measurement data of actual worker exposures, study investigators concluded, based on the detection of 30-nm nanoparticles in the paste material as well as in accumulated dust in the workplace, that these workers were exposed to polyacrylate nanoparticles. Reporting the presence of similarly-sized nanoparticles in the chest fluid and lung cells of the diseased workers, Song et al. highlighted the emerging body of nanotoxicological evidence from animal and in vitro studies to support their conclusion that the observed health effects were due to polyacrylate nanoparticle exposures.

While highly tragic and certain to create a stir among regulators, the media, and the general public, it is important to recognize that this study does more to highlight the critical need to follow well-established industrial hygiene practices than to provide direct evidence in humans of any unique health risks posed by ENPs. This study has several key limitations, including a general lack of information on the exposures experienced by the workers. Given the spraying of a chemical paste and the heating of a plastic material in an enclosed space lacking any mechanical ventilation, it is clear that these workers were exposed to a complex cocktail of chemicals and fumes, in addition to any nanoparticle exposures.

Based on the identification of nanoparticles in the paste, in accumulated dust in the workplace, and in lung tissues and cells of the workers, it is likely that these workers were exposed to nanoparticles in their workplace. However, Song et al. do not provide the necessary materials characterization data to demonstrate that the observed nanoparticles are indeed engineered nanoparticles (i.e., nanoscale particles intentionally created to have nano properties) and to confirm that the nanoparticles observed in the paint paste are the same nanoparticles identified in the workplace dust and in biological samples. Incidental nanoparticles are ubiquitous in indoor and outdoor air from a variety of anthropogenic and natural sources (engine exhaust, metal fumes, secondary organic aerosols), and characterization data are thus needed to confirm that the nanoparticles observed in the dust and in biological samples are indeed polyacrylate nanoparticles.

Given the lack of chemical analysis of the nanoparticles and the workers’ co-exposures to a variety of other toxic substances, it remains highly uncertain to what extent workplace nanoparticle exposures, compared to other workplace exposures, may have contributed to the observed health effects. Further, toxicological evidence cited by the investigators as linking ENP such as carbon nanotubes and zinc oxide with toxic responses in animals and cell cultures is of dubious relevance to polyacrylate nanoparticles, which are unlikely to exhibit similar biological activity due to important differences in toxicologically-relevant properties, in particular chemical composition. Scientific evidence is quite clear that toxicological properties differ greatly among different nanoparticles.

Regardless of the actual role of nanoparticles in the observed health effects, there are important lessons that can be learned from this study. In particular, given the limited knowledge regarding the health and safety risks posed by ENPs, it is imperative that best management practices for workplace exposures be followed to control and minimize potential exposures. It is clear that occasional use of cotton gauze masks, as reported by Song et al. for the Chinese workers, is not an adequate practice for controlling workplace exposures. Fortunately, a number of good resources are available for identifying state-of-the-art nano practices, including the ICON GoodNanoGuide . This study also highlights the critical need for robust exposure assessments to support health effects studies, providing data to characterize key nanoparticle properties and to differentiate ENPs from incidental nanoparticles.

In summary, this study highlights the importance of continued vigilance for any signs of ENP-related illnesses in exposed human populations. However, it lacks the essential materials characterization, exposure, and toxicity data for both the ENP and the other chemicals to which the workers were exposed. Thus, the study is not supportive of the authors' conclusions that ENP exposures underlie the observed health effects among the Chinese workers and that these findings are of relevance to all commercially available ENPs.
 

Another Nano-Silver Sock Study

We have previously reported on a study by Arizona State researchers looking into the potential release of nanosilver particles from odor-killing socks during theoretical wash cycles.  A new study from Switzerland examines the issue in further detail.

L. Geranio, et al., "The Behavior of Silver Nanotextiles during Washing," Environ. Sci. Technol. (Sept. 2009).

Three authors from the Swiss Federal Laboratories for Materials Testing and Research conducted the study with the aim of determining "the amount and the form of Ag released during washing from nine fabrics with different ways of silver incorporation into or onto the fibers."  The study generally found that when washed at low pH levels, there was little dissolution of nanoparticles from the textiles being tested.  However, the researchers theorized that the use of bleach "can greatly accelerate the dissolution of Ag."  The percentage of total silver emitted during one wash cycle for the fabrics varied between 1% and 45%.  Almost 75% of the silver released was greater than 450 nm in diameter. 


 

New Article: Examples of Recent EPA Regulation of Nanoscale Materials Under the Toxic Substances Control Act

Nanotechnology Law & Business just published our new article on the EPA's recent treatment of nanoscale materials under the Toxic Substances Control Act.  An abstract for the article is below and you can find a copy of the article itself here.

Abstract: This article provides a summary of recent (2008-2009) regulatory efforts by the U.S. Environmental Protection Agency under the Toxic Substances Control Act concerning nanoscale materials. These efforts include entering into two consent orders with a manufacturer of carbon nanotubes; issuing four significant new use rules for two siloxane-based nanoparticles and two carbon nanotubes (and then withdrawing the latter two); intimating that new testing and data collection rules will be implemented for certain nanoscale materials; and proposing and/or requiring acute toxicity rat inhalation testing regimes in certain instances. The authors explain these developments in detail and then provide some initial strategic and legal considerations for businesses attempting to navigate this emerging regulatory thicket.

Fantastic Voyage II: Nanotech Motors

When I was growing up, one of the local tv channels in Baltimore, after football season was over, devoted Sunday afternoons to running old movies. One of those films was Fantastic Voyage, a fairly slick 1966 sf film. The plot of the movie revolved around a submarine and its crew being shrunk to the point where they could be injected into a human vein with the mission of finding and dissolving a blood clot lodged in the brain of a scientist defecting from an unnamed Iron Curtain nation.

The plot and acting ranged from the thoroughly absurd to the god awful bad, but the special effects were top of the line for that period of film making (okay, the scene of Donald Pleasance' villain being devoured by a white blood cell that looks more like slowly poured soap bubbles is a hoot and a half, but it worked . . . sort of.) The image that stays in the mind is of the sub just gliding through the blood steam.

Fantastic Voyage leapt up from the depths of my memories while I was reading "How to Build Nanotech Motors" , by Thomas E. Mallouk and Ayusman Sen and published in the May issue of Scientific American briefly reviews nanocar experiments and focuses on two problems with nanocars: (1) how to power them and (2) how to steer them. The article discusses progress made in developing "motors" to power the nanomobile and controlling its direction via the manipulation of magnetic fields.

Mallouk and Sen's vision of the future of the nanocar is more one of nanotrucks, carrying cargoes of drugs to areas of the human body where no ordinary delivery system can reach. For example, anticancer medications could be carried directly to the site of the tumor and delivered without affecting the surrounding healthy cells, much as the crew of the sub reached their blood clot and dissolved it without damaging the other brain cells. This is one area of nanomedicine that I think everyone hopes will reach its full potential.

As for Fantastic Voyage,  the producers and director of Independence Day are working on a remake, scheduled to come out in 2010. If its anything like the remake of Godzilla, do yourself a favour and watch the original.

 

 

Ohio 7th in Nanotech and Microtech Innovation

The Cleveland Plain Dealer recently reported on Ohio's standing in nanotechnology and microtechnology innovation.  According to Small Times Magazine, Ohio is now 7th in the nation, returning to the top 10 after dropping off last year.  This puts Ohio in good company with nanotech heavyweights Massachusetts (#3), New Mexico (#2), and California (#1).