When It Comes to Nano, Feds are Passing the Buckyball
According to an article from Scientific American, the National Research Council has weighed in on the regulatory efforts of the federal agencies responsible for monitoring the safety and use of nanoparticles and objects using nanotechnologies.

For the more than 800 consumer products using nanotechnology, the NRC has said that no federal agency including FDA and EPA "has failed to prove that the diminutive particles are not dangerous." Of course, this isn't the same as saying the particles ARE dangerous. But if the standard being used by the government is to prove that nanotechnologies are SAFE, not just that they aren't harmful. Then no agency has proven that yet.
Moreover, the NRC has said that National Nanotechnology Initiative, the overarching government plan to fund and oversee nanotechnology in the United States, "lacks a coherent plan for ensuring that current and future uses of nanotechnology do not pose a risk to human health or the environment."
So what does this mean for the average human being? Well, we know that there are exposures to nanoparticles in everyday life--but we simply don't know what significance that risk has. Without that data, regulation to ensure that those levels aren't breached or that certain products do not contain to great a level of a certain chemical or compound does not do much good.
So really there are two problems here: lack of research funding for risk assessment and epidemiological data regarding what we know about the nanoparticles already released in the environment and then the regulatory framework to enforce reasonable policies based on that data.
So it's time for the federal government to start spending the research dollars in the right areas, then pass the regulations necessary, and to stop passing the buckyball.
Summer Johnson, PhD
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I am just browsing and this comment caught my eye. This blog entry strikes one as being poorly reasoned.
1. The author makes a dangerously misleading statement about safety and harm, stating that showing something is not harmful is different from showing that thing is safe. Common sense tells us that if something is not harmful it is safe. In fact, in common usage safety is defined as non-harmful. But, I accept we are bioethicists with various backgrounds and that the obvious is not always the answer.
According to some logical models, including the ones typically subscribed to in analytic scientific usage, one can never prove the general from the specific in the life sciences. The is the famous problem of induction. Biostatisticians, epidemiologists and other users of quantitative methodology recognize this with "margins of error," "tolerances," "standard deviations" and so on. So, when SJ makes the statement non-harmfulness and safety are not the same she should say something to indicate where she draws the line, because absolute safety in this context is unlikely to be determinable or absolute for any or all individuals. It is a statistical matter. It is naive to say it can be proven safe without reference to at least the idea of a definition of safety.
A definition of safety would raise an issues that perhaps SJ wishes to avoid, to wit, the precautionary principle, a cornerstone of public health ethics. There is no reasoning typically associated with the PP in the comment, even though the problem is framed as one of the PP. PP reasoning would ask the question alluded to above: what is a safe level of exposure? that is the question policy makers struggle with.
2. i think she may wish to avoid the issue, or perhaps does not think it is a useful policy-making tool, because in a later paragraph she says that:
"Well, we know that there are exposures to nanoparticles in everyday life--but we simply don't know what significance that risk has. Without that data, regulation to ensure that those levels aren't breached or that certain products do not contain to great a level of a certain chemical or compound does not do much good."
In other words, until we can conclusively evaluate the safety of nanoparticles, then we can let them be spread through the environment because regulation does not make sense in the absence of that conclusive safety data. Remember, that level of safety data is not only impossible to attain (see above), but it will take many years, perhaps many decades, before the health effects of the exposures will be known, and then only if third-party observers are watching closely. This is a situation of no knowledge and the potential for extremely widespread exposures. Since the PP is not available as a conceptual tool, the answer, asserts SJ, is no regulation because we do not have empirical data. That, of course, is exactly what industry, the technology owner, wants and the message it seeks to embed in the public's mind. Being experts though, we are supposed to be able to see through the marketing hype. That level of capitulation to industry by experts, such as ourselves, the self-appointed watchdogs of public health, is associated with the degradation of the entire public health infrastructure, the regulatory environment, under the conservative administrations of the last 39 years.
Bioethicists should feel confortable grappling realistically with the idea industry, including the NIH/FDA/Pharma axis and the chemical sector, should be firmly regulated, and that new products for which no safety information exists should not be allowed willy-nilly into the market, regardless of the value placed on the idea of scientific progress (esp. when it is closely related to capitalist progress). The rush to market is driven by patent laws, which typically give market protection to the patent holder for about 20 years. Well, determining safety for these "products" is at least a 20 year epidemiological project. If health is a human right, or the access to health providers and provisions is a human right, and if health is a common good, then the entire idea health products can be patented and removed from the common domain and remain unregulated is an insult to human dignity.
The ethical evaluation of emerging technology is not something that can be done within one domain. Human rights, property theory, economic theory, regulatory theory, etc. coincide with public health ethics, and other ethical subdomains of the ethics of the life sciences. There are much reasoning about "right" to be undertaken as we regulate the unknown for the benefit of the unborn.
I realize from the numerous grammatical mistakes in the piece that the author must have been in a holiday rush, or perhaps it was written by an intern, but we should expect a little more from this well-known blog.
- by john lunstroth on Jan 3, 2009 at 3:40 PM | link
Thank you, Dr. Lunstroth, for your comment. My point very simply is that the federal government has made an insufficient effort to regulate nanotechnology, which could have been done either through a single super-agency or through the various agencies who have dominion over the various products and projects into which it has poured tens of billions of dollars to promote nanotechnology research. The excitement over nanotechnology overshadowed the prudent planning that should have gone into simultaneously building into the funding of nanotechnology R&D regulations to protect workers with OSHA, sufficient funding for environmental and workplace studies regarding the effects of nanoparticles with EPA and OSHA and other agencies, and while this was done to a certain extent, not enough money was put into the risk assessment, evaluation and monitoring in proportion to the R&D. My fear is that we don't know what to fear that that we will end up demonizing a technology that we don't even fully understand, or alternatively the horse will be let out of the barn and the damage will be done already and it will be too late to fix it. I don't know, as I am neither an epidemiologist nor a material scientist, engineer, or chemist, which to worry about more, but one of those scenarios will happen. We should do what we can to prevent both extremes and it is our government's job to do so.
- by Summer Johnson, PhD on Jan 4, 2009 at 11:52 AM | link
John Lunstroth writes: "I realize from the numerous grammatical mistakes in the piece that the author must have been in a holiday rush, or perhaps it was written by an intern, but we should expect a little more from this well-known blog."
Just to clarify, John, I am assuming that you didn't intend the ad hominem that you appear to be making, to the effect that *signed* posts, in the oldest blog by the editors of a scholarly journal, an ethics blog, are ghost written, or that typos in a posting on a blog represent evidence of defective analysis. Your comment was approved because the post's author Dr. Johnson took it to be substantive, though I suppose I don't agree, given that the precautionary principle is self-evidently nonsensical, its invocation mandatory only on other planets where naked intuitionism is a viable form of moral theory, and your invocation of "PP" for the purposes of critique of the post's political claim about institutional matters in the regulation of nanotechnology is incoherent, in my view. However, I might also have let the comment through, were it not for your ad hominem. Just to remind you and others who might miss this fact, we give a clear statement of our policy with regard to posting rude or insulting commentary in a number of places in the blog. Next time, take a deep breath before submitting a comment or send it by email to the author. - Glenn McGee, Editor in Chief
- by Glenn McGee on Jan 6, 2009 at 12:48 AM | link