Nanoscale materials used in everything from food packaging to industrial chemicals to medical devices may soon be regulated by the Environmental Protection Agency in the US, and by other regulatory bodies in Europe and Japan.
The EPA has proposed mandatory reporting rules for nanomaterials under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and is developing comprehensive regulations under the Toxic Substances Control Act (TSCA). The TSCA regulations would include four areas: premanufacture notification, a Significant New Use Rule (SNUR), an information gathering rule, and a test rule.
But a recent report by the EPA's Office of Inspector General (OIG) found "that EPA does not currently have sufficient information or processes to effectively manage the human health and environmental risks of nanomaterials." The report says that, although the EPA has the statutory authority to regulate nanomaterials, at present it "lacks the environmental and human health exposure and toxicological data to do so effectively."
Even if mandatory reporting rules for nanomaterials are approved, says the report, the effectiveness of the EPA's ability to manage nanomaterials risks remains in question for four main reasons. These are: the lack of a formal process for coordinating and disseminating mandated information; the lack of an overall message to external stakeholders about policy changes and risks; regulating nanomaterials as chemicals will be limited by the limitations of existing statutes; and a lack of information about risks and a reliance on industry-submitted data.
In the report, the OIG recommends that "the Assistant Administrator for Chemical Safety and Pollution Prevention develop a process to assure effective dissemination and coordination of nanomaterial information across relevant program offices." The report also states that the EPA agreed with its recommendation and provided a corrective action plan. By January 31, 2012, the EPA is to convene a workgroup to begin development of this process, and by July 31, 2012, the EPA will complete a draft document outlining the process.
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?
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.
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.
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.
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.
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.
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.
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.
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