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

Author Michael Berger points out the problems with the length of time in publishing the results of scientific studies in relation to the freshness of the data.  Without repeating his well written piece, there are some particularly interesting points, such as:

• A peer-reviewed paper takes almost 2 years to publish once the scientific research is completed;
• In a fast-growing field like nanotechnology, the knowledge contained within the field doubles roughly every five years (however, he does not define what "knowledge" means in this context)

He's got some other good points and examples, but I don't want to spoil the ending for you.

This raises the fairly obvious problem that the published results of research may very well be outdated and stale by the time the research paper is in circulation.  It is an interesting read, and one I recommend (and it'll only take about 10 minutes). 

Clearly, the delay from research to publication is a problem.  As we've talked about here before, the "data gap" that exists is one of, if not the, major barrier to nanotechnology regulation and addressing the health and safety issues that are at the front of everyone's mind.  But how to get the fast-paced information out faster?  One of Mr. Berger's suggestions is a wiki, which we've talked about before and which ICON is proposing be used for "good practices" development.  Maybe this format will work for peer-reviewed research as well (if any researchers out there are reading this, I'd be curious to know your thoughts).

Regardless, Mr. Berger and Nanowerk are correct: something has got to give between the slow pace of publication and the fast pace of the sector.  What good is information that's two years old and new information has been revealed in the interim?  Is there room to improve the system, or is the process of peer-reviewing the best we have?  Something to think on for a while.

The author, Michael Berger, lists the following five problems with regards to a lack of consistent nanotechnology standardization:

• "no internationally agreed terminology/definitions for nanotechnology
• no internationally agreed protocols for toxicity testing of nanoparticles
• no standardized protocols for evaluating environmental impact of nanoparticles
• no standardized measurement techniques and instruments
• no standardized calibration procedures and certified references materials"

In addition, there are no fewer than seven organizations with competing nanotechnology standards statements, including ASTM, ANSI, IEEE, and ISO--all well respected organizations.  In addition, the nanotechnology standards debate has been going since at least December of 2003.

Well, this got me to thinking.  In an instance of life imitating life, the competing technical standards for nanotechnology closely resembles the diverging regulatory standards that are developing (oh, c'mon, you knew where I was going with this didn't you?).

For example, take a look at the three state statutes concerning the definition of "nanotechnology."  Each of Michigan, Arkansas, and Oklahoma have enacted binding, statewide laws concerning what defines nanotechnology:

• Arkansas, A.C.A. §15-4-2103(5): “Materials and systems whose structures and components exhibit novel and significantly improved physical, chemical, and biological properties, phenomena, and processes due to their nanoscale size;"
• Oklahoma, 74 Okl St. Ann. §5060.4(12): “‘Technology developed at the molecular range (1 nm to 100 nm) to create and use structures, devices, and systems that have novel properties because of their small size;"
• Michigan, M.C.L.A. 206.30 -125.2088a: “Materials, devices, or systems at the atomic, molecular, or macromolecular level with a scale measured in nanometers;"

Now, take a look at the bold sections.  All three of these statements concerning the size of nanotechnology have slightly different meanings.  In fact, only one, Oklahoma, actually defines nanotechnology as existing between 1-100 nanometers.  While this may not seem to be an overly important consideration now, imagine what these further regulations in these states will look like with diverging bases.  Add to these emerging state statutes the previously discussed Berkeley standards, and the forthcoming Cambridge standards, and a very murky picture begins to develop indeed. 

While I am not suggesting that there should be one, all-inclusive set of regulatory standards for nanotechnology, I am suggesting that we need to be mindful of these diverging paths and strive to reduce uncertainty and confusion by the regulated community as these standards develop.  Just like consistent technical standards will provide certainty to the scientific community, developing regulatory standards with an eye towards consistency will provide certainty for the regulated community.