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

The report, found here, made several observations and conclusions.  Among the highlights are:

• $37.7 million dollars, or 3% of the federally allocated $1.3 billion for nanotechnology research, focused on EH&S risks;
• Of the 119 research projects claiming to focus on EH&S risks, GAO determined that 22 projects, or 20%, did not in fact focus on EH&S risks.  Instead, these projects were environmental remediation or hazard identification focused, and the mischaracterization was due to flaws in the classification process (as an aside, GAO conducted a follow-up study to this point, and released a subsequent report in late April entitled: "NANOTECHNOLOGY Accuracy of Data on Federally Funded Environmental, Health, and Safety Research Could Be Improved");
• EH&S research projects conducted in 2006 were "generally consistent" with agency goals;
• Federal agency and NNI efforts to coordinate research activities related to EH&S risks "have been generally effective."

GAO went on to recommend that the Office of Science and Technology Policy (OSTP), the office that administers the NNI, "provide better guidance to agencies regarding how to report research that is primarily focused on EH&S risks.  In commenting on a draft of this report, OSTP generally agreed with the findings and will review the manner in which agencies respond to current guidance."  The same recommendations were made in the April report as well.

While not getting to nanotechnology regulations directly, GAO studies are an important indicator of where research dollars are going, and how effectively they are being used.  I don't think the conclusion that better guidance is needed, or that the reporting classifications can stand to be more accurate, comes as any great shock to those working in the sector.  However, having the GAO spotlight on the issue will help to resolve the problems and will force affected agencies to examine their processes and methods.

Maynard indicated the primary purpose of the article was to motivate scientists to put in place within the next 12 months a long-term plan for conducting the necessary environmental, health, and safety research in this area. Maynard expounded on five "Grand Challenges" the authors believe are key to forming a robust, world-wide nano-EHS research plan:

1. Creating new instrumentation to measure possible exposure to nanomaterials through air by 2010 and water by 2012, leading to “smart” nanosensors with the ability to detect potential exposure hazards and identify potential environmental and/or health reactions by 2017;

2. Establishing effective and relevant nanotoxicology testing methods world-wide which combine applicable existing testing methods with new cutting edge technologies. International nanotoxicology testing protocols would be established by 2012; effective alternatives to in vitro testing would be created by 2022; and a final answer to any questions regarding the potential toxicity of fiber-shaped nanomaterials (such as carbon nanotubes) by 2012;

3. Creating systems that can predict the potential impact of new nanomaterials on the environment and in the body, leading to finalized methods for engineering safely designed nanomaterials by 2017;
4. Developing systems and methods that enable scientists to assess the potential impact of nanomaterials during their entire life-cycle from cradle to grave;

5. Devising effective research programs to accomplish the four above-referenced Challenges. In order to maintain the authors’ developmental time-line, Maynard indicated that this challenge would need to be met within the next twelve (12) months and would involve collaboration, communication, and coordination between international governments, scientists, and industry representatives.

Maynard concluded by stressing that mastering these Grand Challenges will allow the nano-industry to make decisions regarding any potential nano-EHS risks posed by its products based on sound science, not continued speculation.

Tinkle further elaborated several broad concepts embedded within the Grand Challenges:

1. Establishing a research pipeline to coordinate nano-EHS research, including identifying and sealing any gaps in the pipeline between (i) basic nanoscience; (ii) nano-application engineering; and (iii) nano-decision making at the product and policy making level;

2. Identifying cross-cutting themes and research concepts that can be used between scientific disciplines;

3. Combining traditional research methods with cutting edge research strategies; and

4. Establishing partnerships among international governments and international scientists to jointly addresses research needs.

Of note, audience members asked Maynard and Tinkle follow-up questions concerning (i) budgetary requirements for the authors’ proposal, (ii) whether this time-line could somehow be sped up; (iii) how to balance this nano-EHS research time-line against the burgeoning commercial market for nano-based products; and (iv) the efficacy of existing nanotoxicology testing methods.



The authors’ article an be found at “Safe handling of nanotechnology,” Nature, Volume 444 Number 7117 pp. 243-400 (November 16, 2006)



JCM: While the authors' five Grand Challenges provide a much-needed framework, current nanomanufacturers should consider what they can and should do to protect themselves from potential consumer litigation during the next seven (7) to twelve (12) years while the scientists sort this all out.  I am not sure plaintiffs attorneys and consumers will have the patience required by this proposal. 

For reference purposes, the author's time-line is conveniently summarized in a graphic contained in the Nature article.