I would imagine that potential legislation governing nanoscale materials has to be a good thing in terms of promoting a healthy and safe environment not only for workers using the new materials, but also end users of products that leverage the new technologies. That said, one can only imagine that legislation might curtail usage and further evolution of these important technologies. Is that the case, Ann? How widespread is nanomaterials so far?
Nanomaterials are extremely widespread at present, Beth, and they're by no means monolithic in shape, size or constitution. They're in food and cosmetics, where much of the consumer-level concern is, but also in a lot of materials being produced in factories, like the industrial chemicals and medical devices mentioned in the article, so there's also concern about worker exposure. In fact, a coalition of consumer safety and environmental groups sued the FDA in December over possible risks from nanomaterials:
During the reporting of this story, I was reminded of the parallel issues surrounding the maintenance and repair of carbon fiber composites in aircraft, most especially the absence of repair databases and procedures and the difficulty of determining whether damage has even occurred. But in the case of aircraft composites, much of the information is either gettable or available, since composites use in aircraft is not entirely new. In the case of nanomaterials, practically everything is new and very little is known about their effects on human health.
Nice article, Ann. As with a lot of environmental legislation, the EPA may wait to see what Japan and Europe do before offering any significant regulation. Even then they may hang back. We still don't have a a U.S. RoHS. We don't really need one, since the electronics industry complied to Europe's regulation.
Thanks, Rob, for weighing in with your expertise on related legislation. I think one of the problems here is that the subject potentially either bridges, or falls between the cracks of, some different interests and expertise areas: health, environmental and technological. That's why we're seeing FDA, EPA and NGOs involved, and that will make the legislative and regulatory situation a lot more complex.
I agree, Ann. The different entities each have their own communities to satisfy. It will be interesting to see how this turns out. There will also likely be political aspects to this since this is an election year.
The Inspector General's report points to the lack of good information about the health effects of nanomaterials. Some recentstudies have found possible heath risks associated with carbon nanotubes. This is an area which needs further study. We are only just beginning to learn how materials behave on this scale, never mind how they interact with complex biological organisms such as ourselves.
Dave, thanks for your comments and those links. I think you are totally right on. Much of the research I saw has to do with simply classifying and describing various different types of nanomaterials, and none with their effects. That pattern tells me that a field of study is in its infancy. I find that pretty scary, and am still amazed at how fast these technologies were allowed to grow without being studied first. The concern about their effects is by no means new: I read about it when I was covering this topic a decade ago for a different publication, and as usual, commercial interests trumped safety interests.
Like so many other areas of technology today, this is a case of a technology developing too quickly for researchers and governing agencies to study it and come to any conclusions. We're seeing the same thing in the auto industry, where the pace of electronic development is exceeding the ability of governing agencies to understand the implications.
Chuck, I think you're right. I've seen the same pattern elsewhere to varying degrees, depending on the nature of the technology and its degree of comprehensibility or incomprehensibility to the average non-technical person. In nanomaterials it's been especially problematic because they're especially difficult to comprehend, rather like the early SoCs were to many average folks.
Good points Chuck and Ann. You have to wonder whether the regulatory agencies have the expertise to develop reasonable regulations. RoHS received considerable criticism for not providing sufficient science behind its materials bans. The RoHS folks have made adjustments going forward to respond to scientific challenges.
I can't imagine how this is going work with nanomaterial.
This is definitely one area where legislation could forestall innovation. As well, regulating nanomaterials as chemicals makes no sense in the case of MEMS devices. Under these proposed regulations, MEMS sensors could conceivably fall under these laws. Not a good idea, or one that makes any sense.
@Alex: Looking at the EPA documents which Ann linked to, I didn't get the sense that MEMS devices would be likely to fall under the proposed regulations. It seems like EPA is primarily looking at nanomaterials such as fullerenes and nanotubes. I agree that any regulations made in the absence of good information have the potential do more harm than good. On the other hand, the basic physics (let alone the biological activity!) of these materials is only partially understood at this point, so it makes sense to proceed with a certain amount of caution. OSHA has a page with links to many resources on the health effects of nanomaterials.
Thanks for that update, Dave. It's good to know that the proposed legislation don't seem to extend to MEMS devices. Perhaps this legislative effort will end up like the radiated-food stuff did several years back, which was that lawmaking was ahead of a technology which had yet to settle or to come into a common mode of usage. So the legislative process was being attempted too early on the adoption curve. Sounds like the same thing is happening here.
Thanks, Dave. It's important to clarify that MEMS are definitely not being considered here. MEMS and nanometer-level tech of various kinds are often mentioned in the same breath, and that's sometimes unfortunate because it's confusing. Generally speaking, MEMS are usually quite a bit larger--often another order of magnitude--and may be made of nano-sized components.
That said, I also think it would be silly for the EPA to try to regulate all nanomaterials as chemicals, but I'm not sure that's actually what they intend. I think that's just a starting point and that all the regulatory bodies are flailing around. As Rob's comments indicate, regulators seem to have been blindsided by all this commotion. But they have to start somewhere.
As Dave points out, there's reason for concern with some nanomaterials. And I've always thought, if you introduce a new variable into any system, it's naive to work on a default assumption that there will be no effects. If the systems are individual, biological ones--like me or you--then it behooves us to know what we're doing.
Ron, I would certainly anticipate that even a total lack of understanding would prevent the regulatory agencies from creating all sorts of rules about how to handle things. It has not slwed them in the past, why should it slow them now. What evidence is there that the new nano materials are any more hazardous than dust has been for hundreds of years? Or aerosols, for that matter.
I would not anticipate that the first set of regulations will be rational at all. Nor that a lack of understanding will slow the rate of regulation.
@William K.: Obviously nanomaterials have vastly different properties than common dust particles, otherwise they wouldn't have any scientific interest or commercial value. Quantum size effects result in nanoscale materials behaving in radically different ways than bulk materials. They have different mechanical properties, electrical properties, chemical reactivity, etc. So why is it reasonable to assume that when it comes to their health effects, they behave the same as common dust?
Of course, common dust particles are far from benign themselves. Effective regulation has nearly eliminated silicosis as a cause of death in the U.S., but it continues to kill thousands of people in China every year. And silicosis is caused by micron-scale particles which can be easily stopped with a properly designed and fitted dust mask. How do you effectively filter out nanoscale particles?
At any rate, the regulations which EPA is proposing would simply require companies to report where they are using nanomaterials, and how much. They wouldn't impose any actual restrictions on the use of nanomaterials. And the only reason why EPA is even considering mandatory reporting is that not enough companies are participating in an existing voluntary program.
Requiring companies to report their nanomaterials usage might help to address the lack of information which is currently the biggest impediment to assessing and managing nanomaterials risk. The only companies which I would expect this to have a serious negative impact on would be the ones who claim to be using nanomaterials in their products and actually aren't.
Thanks, Dave, for the clarifications about legislation and regulation and for pointing out the particle size issues and enormous size differences, in turn causing behavioral differences. And of course, the effects of those differences are mostly unknown at present.
Your assessment is interesting.
Aspects to be considered in classification require careful analysis.
1. Is the nano material an active or passive bio-component
Dust is micron sizable material that activates predisposition human bio-systems.
Drugs have been in the market, approved by FDA, to a specific volumetric concentration and contain aerobic nano particles, altering biosystememic tissue, organs and behavior.
Chemicals (pool chemicals, herbicides, and even car pollution 50 microns size particles) are active human bio-component a
EPA & FDA
Legislation or Guidance
Disclosure or non disclosure
2. A great number of nano materials are active components of sealed and totally enclosed systems with potential for bio-analysis.
i.e. Medical nano devices.
Concerns? It is a component quality to process validation issue.
3. A number of newly bio- nano systems are fuel producing and cell generating systems
Concerns? Less polluting biodegradable fuels ;)
Reconstructive StemCell human tissue and organs ;)
An Army of Nano-Drones ;)
From Mouse to NanoDrones - It is a real legal & ethical question and concern.
4. The sky is the limit!
Not to nit-pick excessively, but there is a big difference between legislation and regulation. Legislation is done by the legislative branch. Regulation is done by the executive branch, under authority granted to it by the legislative branch. What's being discussed in this article is regulation, not legislation. (Thanks to partisan divisions, the U.S. Congress is not very likely to pass much legislation on any subject in the next twelve months).
The Inspector General's report basically says that EPA has the authority under existing law to regulate nanomaterials, but that they don't have enough information to do so in a meaningful way.
By the way, it's interesting to read the bickering between the EPA and the Inspector General's office in the appendix. The report originally had a more scathing title.
Dave agree with your comments, Wonder, and it will be extreamly interesting, to discover WHO will wind up doing all this work especially since manufacturing processes and safety testing is still in development world wide.
Dave, I also, appreciate the clarification about nanomaterials. My comments about the EPA are due to their history of issuing edicts, however. A bad reputation is a difficult thing to lose, and while some applaude all of the EPA rules, I find that many of the assumptions appear to be built on questionable statistics, at least, on statistics that don't seem to be atributed to a recognized source.
The first step in regulation is almost always to find out who would be regulated, so as to be able to apply force to all involved parties when laws are finally passed. So it looks obvious to me that regulation is going to happen in the fairly near future, probably before much long term data has been collected. IT just seems to work that way.
On the other side, are there any examples of anything being caused by people either breathing or becoming contaminated with any nanomaterials? A detailed pathological report on any instances would be quite worthwhile. A good writer could translate it into common language from the medical jargon and allow us to know "what really did happen".
I think Ozark Sage has raised a very good question: who will do the testing and various types of assessments that result in regulation? So far, it looks like the state of knowledge is still stuck at the classification stage.
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