What is the purpose of regulations? Regulations are rules/laws or directives created and maintained by an authority that is intended to govern conduct/actions. Ideally, the purpose of the regulation is to ensure the safety of the public and prevent situation that may cause harm. In many cases, a vocal group may create a sufficient presence to prevail/prevent the action they are interested in moderating.
How do we create regulations? In many cases, investigations are made (hopefully, but neutral parties) and finding are developed so that recommendations can be provided. Many governmental agencies will then provide a period of time for public review and comment. Taking the public input, the agencies will then develop and publish their regulations with an effective date. Normally, there are consequences for non-compliance. So how can this go wrong?
One potential problem is that scientific research has a number of efforts that are not scientific in the true sense. If there is a hypothesis that the investigation is testing, then a proof that the hypothesis is not true should result in rejecting the hypothesis. Unfortunately, this is not always the case. Human nature creates an ownership in efforts after a period of time. My observations put this at between three and one-half and four years. After that time, many people tend to develop an identification with the effort and are reluctant to accept an outcome that is different from that which was anticipated. At this point do they change the hypothesis or try to modify the experiments or data included to validate the original hypothesis?
Another point is that regulators are not normally unbiased experts in the field they are regulating. Their intentions a good, but the effect of what they are trying to regulate may not turn out the way they intended. The city of Berkeley, California is one example that I think provides an interesting perspective. In December 2007, the city passed an ordinance (regulation) that any nanomaterials brought into the city for research must have a Material Safety Data Sheet (MSDS). At that time, there were not any MSDS available on carbon nanotubes (CNTs). Since developing an MSDS takes not insignificant time or effort, there were two choices. The first was to stop all efforts in CNTs. If you had been working in this area for some time, it would require giving up your work and probably your funding. This is not really acceptable. The other option was to find a material that is very close to what you are working on and employ that description to your material. Well, graphite consists of carbon and probably has some nanotubes somewhere in a batch of material. Is that an acceptable substation of an MSDS? Is this what the regulation intended? Were there other choices for the researchers? Who really benefited?
Why this blog on regulations? There are regulation by the both the EU and the U.S. that are attempting to cover potential situation that might occur. The issue that exists with over-broad regulations is that they are inaccurate. If the regulation stipulates the handling and transportation of nanomaterials, how does one differentiate among the various sizes within the classification of what is a nanomaterial? Does 80 nm versus 25 nm make a difference? In the case of some metals, the answer is absolutely yes. Since, precise measurement of size distribution for a large quantity of nanomaterials is extremely challenging, are batches of nanomaterials with a half-width of 2 nm and 20 nm to be considered the same material? Since there are estimated to be at least 10 to the 200 power different nanomaterials, there is no means of testing each and every one of them. As always, proceed with caution.
