EPA Issues Significant New Use Rules for Two Nanomaterials
This article, which appeared in the Nov. 17, 2008 issue of Pesticide & Toxic Chemical News, Volume 37, No. 3, was reproduced with permission from Agra Informa. Further use of this article is prohibited without the express written permission of the publisher. For more information about Pesticide & Toxic Chemical News, Food Chemical News or other Agra Informa publications, go to: www.foodregulation.com .
EPA earlier this month announced it is promulgating significant new use rules (SNURs) under TSCA for two nanomaterials — siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles — that were subject to premanufacture notices (PMNs). Some stakeholders view the move as a further sign that EPA is willing to use its authority to regulate nanomaterials, although to what extent remains uncertain.
Continue Reading...New Registry and Label
Nanosafe, Inc. has recently announced the launch of its new website, the Nanotech Register™ and its new product labeling system, Nanosafe Tested™. The Register is itself the location of all of the products receiving the Nanosafe Tested label. The Nanosafe Tested program, as described by Nanosafe, Inc. is a "program to provide clients with independent third-party testing of nanotechnology products." Specifically, "Products that have been NANOSAFE TESTEDTM are subjected to defined testing criteria developed from peer-reviewed literature and comparable standardized testing methods. Test results are reported in two ways: first, a comprehensive, proprietary test report is provided to the client; second, a one-page, non-proprietary summary report is posted to the NANOTECH REGISTERTM where it may be viewed freely by the general public." The only product on the Registry to this point is, XPert® Nano™ System by
LABCONCO INC.
This is the second (or third, depending on how you count "registries") that are available to the public at this stage (if you know of more, please let us know!). In addition to the Nanosafe Registry, there is also PEN's inventory of products containing nanotechnology and the responses EPA received under the Nanoscale Materials Stewardship Program. While still in its early stages, having an additional registry should be helpful for tracking and continuing to evaluate nanomaterials on the market.
Nano EHS Database
The International Council on Nanotechnology (ICON) just released its newest project/tool, the Nano-EHS Database Analysis Tool. To quote ICON, "This web tool allows you to obtain a quick and thorough synopsis of our Environment, Health and Safety Database using two types of analysis. The first is a Simple Distribution Analysis (pie chart) which compares categories within a specified time range. The second type is a Time Progressive Distribution Analysis (histogram) which compares categories over a specified overall time range and data grouping period." The report will generate data in pdf or xls format as well as a report on available publications based on search categories, such as material studied, target receptors, and type of publication.
While the Tool only tracks ICON's database, it will likely become a valuable resource for literature searches. With the increased importance of regulatory schemes such as TSCA registrations, literature reviews will become more critical, even to smaller operations. ICON's Tool will assist those entities, and others seeking wide ranging topics addressing nanotechnology or nanomaterials.
PDF of "A Nano-Mesothelioma False Alarm"
Nanotechnology Law and Business was kind enough to let us post a PDF of "A Nano-Mesothelioma False Alarm" here after several readers requested a copy.
Please be sure to visit the journal to see the rest of this issue's articles:
- Grading of Fullerene Nanotubes for Composite Applications
- Next Generation Carbon Fiber
- Patenting Graphene: Opportunities and Challenges
- Oxonica v. Neuftec: Nanoparticle Fuel Additive Litigation in the United Kingdom
- Mediating the Uncertainty and Abstraction of Nanotechnology Promotion and Control: “Late” Lessons from Other “Early Warnings” in History
- The Implications of Recent Nanomaterials Toxicity Studies for the Nanotech Community
- A Nano-Mesothelioma False Alarm
- Convergence of Cleantech and Nanotech and the Benefits to the Nanotech Sector
- French and European Community Law on the Nanometric Forms of Chemical Substances: Questions About How the Law Handles Uncertain Risks
- The Validity of European Nanotechnology Patents in Germany
- Book Review of Nanotechnology & Society: Current and Emerging Ethical Issues
- Top Ten Ways Nanotech Will Impact Cleantech
- Updates
A Nano-Mesothelioma False Alarm
For those who are interested, below is the abstract of our new article published in the Fall edition of Nanotechnology Law & Business. You can find the full edition here: www.nanolabweb.com
A Nano-Mesothelioma False Alarm
In May 2008, a scientific study (the “Poland Study”) was published in Nature Nanotechnology—which sparked a rash of popular media claims that like asbestos, exposure to carbon nanotubes may cause mesothelioma. In this article, a team led by lawyer John Monica evaluates the Poland Study in a potential litigation context to determine its significance, if any, in legally establishing that the inhalation of multiwalled carbon nanotubes (“MWCNTs”) causes mesothelioma. After first considering the reliability of the Poland Study's design and execution, they conclude that it would not be admissible in a court of law because it fails Daubert standards. Specifically, they argue that: (i) the design and execution of the Poland Study are not generally accepted in the scientific community for the purposes offered; (ii) in order to reach the conclusion that inhalation of MWCNTs may cause mesothelioma, an expert would have to use the Poland Study in such a manner as to extrapolate from an accepted premise to an unfounded conclusion; and, (iii) the Study's authors failed to adequately account for obvious alternative explanations (confounders), including surface chemistry, sample contamination, sample commingling, spontaneous formation of granulomas, and possible mouse colony infections.
