One of my "go to" nano news sources, Nanowerk, posted an interesting story last week concerning the competing standards that are emerging with regards to the technical side of nanotechnology. The article outlines the various scientific standards that are developing, and the lack of any one overarching, or governing, standard.
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.