Richard Denison, Ph.D., is a Senior Scientist.
As I noted in an earlier post, the federal government staunchly maintains that regulatory agencies’ current authorities and regulatory structures are adequate. Yet I sense quite a bit of angst — even panic — in the agencies over how they will actually address the complexities of nanotechnology under those existing authorities and regulatory structures.
The claim that laws developed long before nanotechnology came along can nevertheless manage it flawlessly smacks of a double standard: If there’s nothing novel here, why is the federal government investing $1.5 billion annually to develop nanotechnology?
It’s like nano promoters who boldly declare in one context – say, when talking to investors – that nano is revolutionary, like nothing that preceded it. But they argue just as vehemently in another setting – say, when talking to regulators – that it’s merely an incremental change in what came before.
Some of us who have been calling for a fresh approach to oversight of nanotechnology have also been accused of trying to impose a double standard, however. It’s unfair, we’re told, to hold nanomaterials to a higher standard of safety than other chemicals by, for example, calling for more upfront testing than is required under TSCA for new conventional chemicals, or seeking to require pre-market review by FDA of nanomaterial-containing cosmetics, when that’s not done for non-nano cosmetics.
I have three responses: First, in a way, our accusers are right: The nano debate does shine a light on what many of us see as broader deficiencies in how we manage all chemicals and products. There’s no question that many limitations to current approaches are not nano-specific, but have been given “new legs” in the nano debate. Our inability to effectively manage risks across the lifecycle is one example. But we should seize this opportunity to illustrate those deficiencies using the fresh backdrop of nanotech – in no small part because they also affect the safety of nanomaterials entering commerce.
Second, the fact is nanotechnology does pose new questions regarding oversight and whether current regulatory concepts are in fact transferable to a nano world. One oft-mentioned example: Regulations are laced with mass-based standards and thresholds, yet there is almost universal agreement – on scientific grounds – that mass is likely to prove a poor dose metric for most if not all nanomaterials. Yet no serious regulatory discussion has started to my knowledge about modifying or adapting the current mass-based regulatory criteria to reflect surface area, particle count or other more appropriate metrics.
Third, if the bar needs to be raised, the time to do it is when a new technology is being introduced, rather than after it has become entrenched – that’s true from an economic efficiency point of view, as well as politically. And as for the argument that we risk stifling innovation, as Mark Greenwood has pointed out, innovators in emerging, fast-moving industries tend to respond and adapt more quickly to address potential problems or concerns than do more – umm – ossified enterprises (be they in business or government).
Nanotechnology offers us the opportunity to solve – in a new, improved way – some thorny, longstanding failures in how society has dealt with the introduction of new technologies. So I just don’t buy the argument that we should go on doing things the way we have been, so we don’t unfairly penalize nano. We should raise the floor, not lower the ceiling!
Still, some observers – noting that most of today’s nanomaterials are variants on existing substances – argue it would be easier and faster just to tweak the current system. I would argue that, even if that were to work for a time, an incremental approach to these new and rapidly evolving materials is bound to break down.
Consider the tortuous legal logic EPA has had to follow in ruling that nano forms of existing chemicals aren’t “new” under TSCA. EPA says the law forbids it from acknowledging the very nano-ness of nanomaterials, namely the fact that their properties are dictated by more than just chemical structure, but also physical attributes.
And that’s just with the current generation of nanomaterials. Now add in more dynamic elements expected to emerge in next-generation nanomaterials, and mixed biological-chemical materials, and so forth. Now is the time to start thinking about how we’re to manage the future of nanotechnology and more generally, these anticipated advances in material technologies.