Recent toxicology studies have given some concern that nanomaterials could poise unique hazards. Technology Review asked Richard Denison, senior scientist at Environmental Defense and a long-time observer of the U.S. environmental regulation system, how we should regulate nanotechnology.
Technology Review: What is your reaction to the recent Woodrow Wilson Center report that called for new legislation to regulate nanotechnology?
Richard Denison: It pinpoints quite nicely the fact that we have a system in place that was built to handle different types of materials than nanomaterials, and that it’s a stretch to argue that it could be easily adapted to fit the unique properties of nanomaterials.
The solution side is tougher. I think it’s useful, although probably optimistic, to be talking about an entirely new law. Useful in the sense that it probably provides a focal point for the debate. Optimistic in the sense that getting any new environmental legislation adopted in this political climate is probably unlikely, to say the least. But I do think that acknowledging that there are serious, systemic gaps in the current system is helpful.
TR: What are some of these gaps?
RD: The example of cosmetics is a very good one. Some of the first applications of nanomaterials are in the realm of cosmetics, and there’s no clear FDA authority to even look at those issues prior to market introduction.
TR: The report suggests that corporations will need to fund tests to prove their new products using nanotechnology are safe. Is this a good idea?
RD: Certainly, companies that stand to ultimately benefit commercially ought to be paying their way.
On the research side, I do think there’s a significant sentiment that some of the federal money that’s now being spent on developing the technology on the R&D side ought to be shifted, so that we have a better balance.
The methods for doing testing for nanomaterials and understanding exposure and how to measure these materials, and so on, really need to be developed through government or government-industry joint initiatives, and then those tools are used by industry to characterize potential risks or to address those risks for the materials that they are putting into the market.
TR: It’s been argued that regulation, even if corporations have to pay for it, will be good for the nanotechnology industry.
RD: We have an ethic in this country that has put the burden by and large on government to prove harm. The problem with that system – and it’s one that’s being increasingly recognized by companies – is that once those problems come to light, the liability, the reputational damage, and other problems that companies end up facing and paying for can often dwarf the cost of what it would have taken to do a better characterization up front and understand the risks.
Even those companies that think they can totally manage the risks of their material, some of them see a need for, ultimately, a regulatory program that provides some assurance to the public – because it may take only one bad apple to spoil the barrel.
TR: Given the potential benefits, do you think enough companies will regulate voluntarily to make a new law unnecessary?
RD: That remains to be seen. Some of us believe that EPA’s voluntary program should be coupled with a regulation that doesn’t impose any testing requirements, but simply says “tell us what you’re doing.” It insures that EPA gets a full picture of what’s going on. In some ways I think there’s a business argument for this too – that it creates a more level playing field, and companies that do step forward aren’t penalized by being at a disadvantage to companies that are hiding in the weeds.
TR: If a new law proves to be necessary, what should it look like?
RD: I’m certainly not of the view that we know enough right now, even if there was a political will, to lay out prescriptions. It’s going to be an iterative process. We’re climbing a learning curve, and dealing with a bit of a moving target. So we need to retain flexibility; but we need to lay a foundation for ultimately developing a regulatory approach that is comprehensive, allows for innovation, but also provides for public trust and dealing with real risks.
TR: What’s one of the first things that needs to be done?
RD: We absolutely need to have a better research strategy in place that says: here are the questions that need to be answered, and we will have answers to these within two years or three years, and we’re spending the money on the right things.
TR: Will fair regulation of a field as complex as nanotechnology be possible without a radical new approach?
RD: We’ve dealt with some pretty tough issues in regulation and legislation, and I don’t know if nano is so novel or so unique that it’s going to require a whole new approach. We understand the basics of assessing hazard. We understand the basics of assessing exposure and mitigating exposure. Those need to be tailored and adapted to the characteristics of nanomaterials, but I don’t know that we’re talking about anything much more radical than that.
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