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IRA FLATOW, host:

You're listening to TALK OF THE NATION: SCIENCE FRIDAY. I'm Ira Flatow.

Nanotechnology is arguably one of the hottest, if not the hottest fields of technology research today. And it's yielding a bonanza of products that you can buy - hundreds of products, from clothing to cosmetics to car wax. And in many of these products, they use tiny, microscopic particles, nanoparticles, tiny enough up to get into your skin or into your bloodstream.

Just how safe are these particles? How much do we know about how they react once you inhale them or breathe them in or put - get into your skin or put them on a cream?

And that really is a topic up for debate these days. And yesterday, the U.S. Environmental Protection Agency held a public hearing in Virginia, where anyone could comment on the agency's new Nanoscale Materials Stewardship Program. That's a program that the agency is proposing to make sure nanotech won't harm us, or the environment, getting out there into the wildlife.

Right now, the agency is classifying nanotech under the Toxic Substances Control Act. That law passed before nanotech products appeared and it covers pollutants that are bigger than nanoparticles. And the EPA is also proposing that companies voluntarily tell the EPA what their nanotech products involve, what safety steps they're taking to protect workers, customers and the environment. Will these approaches work?

Our guests today both testified at yesterday's hearings and they have slightly opposing views on the issue. Charles Auer is technical director of the EPA's Nanoscale Materials Stewardship Program. He joins us by phone from his office at EPA headquarters in Washington. Welcome to the program.

Dr. CHARLES AUER (Technical director, Environmental Protection Agency Nanoscale Materials Stewardship Program): Thank you, Ira, for having me on your show today.

FLATOW: You're welcome. Dr. Terry Davies was assistant administrator for policy planning and the environment at the EPA under the first Bush administration. He's now senior advisor to the Project on Emerging Nanotechnologies at the Woodrow Wilson Center for International Scholars in Washington, where he published a report last May called, "EPA and Nanotechnology: Oversight in the 21st Century." He joins us from our NPR studios in Washington. Welcome to SCIENCE FRIDAY, Dr. Davies.

Dr. TERRY DAVIES (Senior Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars): Thank you, Ira.

FLATOW: Now, I promised the EPA that Dr. Auer could go on first, so I'm going to keep my promise. You're on, Dr. Auer.

Dr. AUER: Indeed. Thank you, Ira. At EPA, our foremost and primary concern is to protect people and the environment, including protecting them from any potential risks from emerging technologies like nanotechnology. We recognize that nanotechnology has tremendous potential to produce innovative and less polluting products.

But these and other benefits from this new technology can only be realized if there's proper scientific and regulatory oversight to protect the people and the environment. Our oversight on nanoscale materials is well under way under the Toxic Substances Control Act, which is the law that regulates industrial chemicals in the U.S.

We're consulting with leading experts on this topic and getting their advice on how best to do this, and we're also proceeding in an open and transparent manner. We've had a long history at EPA of successfully addressing emerging science issues. And to provide appropriate oversight on nanoscale materials, we're doing four things.

We've developed and are implementing a white paper that outlines our research strategy to develop the science needed to assess these materials. All new chemical nanoscale materials are subject to a regulatory requirement that they be notified to EPA and be reviewed by EPA before their introduction into commerce.

We can then take necessary regulatory actions to control those new chemical nanoscale materials. Then, to complement the new chemicals program, we are bringing forward for comment the Nanoscale Materials Stewardship Program, the subject of the public meeting, from yesterday. We hope to, through this effort, to develop a sound strategy to provide a firm scientific foundation for oversight on existing chemical nanoscale materials.

The program will develop key scientific information and allow EPA to engage with companies to assess and take any appropriate risk-management actions on these existing chemical nanoscale materials.

We think this approach will enable responsible development of this important technology. We expect to have this program development completed this year, and participation initiated in 2008.

FLATOW: All right. I got to have to break in here because I haven't got all that time to finish your statement.

Dr. AUER: Well, finally - I'm almost done.

FLATOW: Okay. Good.

Dr. AUER: Finally, we're working with our international colleagues towards common approaches, as well as shared efforts to develop the test data needed to establish a sound scientific understanding.

FLATOW: Okay. Sounds interesting. What - Dr. Davies, you wrote in a Boston Globe editorial, co-authored with William Ruckelshaus, the first EPA administrator, if I remember correctly, under the Nixon administration...

Dr. DAVIES: That is correct.

FLATOW: ...that you don't think these are adequate enough of measures.

Dr. DAVIES: No, I don't. And a lot of the things that Charlie outlined are necessary and useful. And EPA, for example, on the international level, has been one of the leaders in dealing with nanotechnology. And I think they're to be congratulated on that. But in terms - if you look at yesterday's meeting, there were in fact two papers that EPA issued. One was on the stewardship program, which Charlie mentioned, which is a purely voluntary program and involves simply people submitting information to EPA. EPA is not going to do anything with that information. It's purely a way of educating EPA, if you want, about nanotechnology. That's a useful step, but it's hardly providing any protection for the American public.

More importantly, the second paper that the agency issued dealt with this question of new chemicals. And to understand the context, one has to understand that the Toxic Substances Act only reviews new chemicals for their health and safety. It has some authorities to deal with existing chemicals, but most of those are not usable. They've been struck down by the courts, certainly, were very weak to begin with.

The second paper that EPA issued yesterday said that they will not take size into account when they're defining new chemicals. Now, as you know, size is what defines nanomaterials. So, in effect, the agency has said, when we get a new chemical notification, we don't know, much less care, whether it's nanomaterial or it isn't nanomaterial. And how you can build an adequate regulatory program when you don't take the size of the particle into account -the size of what you're regulating - mystifies me.

FLATOW: Mm-hmm. Charles Auer, does the EPA have enough scientists to actually evaluate what gets - the paperwork that gets - the research that gets handed in there?

Dr. AUER: Yes. Our plan, I think, is very clear in the stewardship papers that we put forward that we would review the information submitted and work with the companies to have them undertake any needed risk management measures. One of the other components of our stewardship program is to have the companies agree in advance to adhere to a basic set of risk management practices as they commercialize these materials.

FLATOW: Dr. Davies. What's wrong with that?

Dr. DAVIES: What's wrong with it is that if you have a purely voluntary program and all you're trying to do is encourage firms to take adequate measures of oversight, it's the bad guys - it's the guys who won't volunteer, who don't get into a voluntary program - that you're concerned about. And that's the reason why voluntary programs don't work in situations like this.

Dr. AUER: If I can comment...

FLATOW: Sure.

Dr. AUER: I think Dr. Davies underestimates the significance of policy paper on new versus existing chemicals. Under this approach, many of the important nanomaterials, such as fullerenes and carbon nanotubes, would be new chemicals and would be therefore subject to regulatory controls. We are applying the current legal framework that exists in the U.S. under the Toxic Substances Control Act. And we think under that framework that metal oxides, such as titanium dioxide that are made at nanoscale, may in fact be existing chemicals. However, we do take the crystal structure of those materials into consideration. And if the crystal structure that the manufacturer intends to commercialize is not on the inventory, that would make it a new chemical.

In addition, any derivatized or functionalized or coded nanoparticles, be they organic or inorganic, those would be subject to new chemical requirements as long as there's a chemical reaction involved in the coding or the derivatization.

FLATOW: Will the EPA do any studies into the risks, environmental risks, posed by nanoparticles?

Dr. AUER: We have a very active research effort, which is growing every year. Our research effort is focused on the environment effects and the environmental fate of nanomaterials. We also, under the stewardship program, have a so-called in-depth component, where we will be working with industry and other stakeholders to develop a testing and research program to provide the scientific understanding needed to deal with these materials.

Dr. DAVIES: I think it's important to point out in this context that of all the money being spent by the federal government on nanotechnology, something between one and three percent is being spent on health and safety studies.

FLATOW: And you write...

Dr. DAVIES: That's not enough.

FLATOW: Yeah, you say we don't have enough knowledge of how they affect, not only the environment but people.

Dr. DAVIES: That's right. You need to do a whole lot more research than is being done. And if I can just return to Charlie's previous comment, nobody knows, because since you don't have to identify whether something is or is not a nanomaterial when you submit it under the Toxic Substances Act, but by my calculation, I think of 15 notices that probably were nanomaterials, 14 of them were decided - and this is in the last couple of years - 14 of them, the agency decided, were existing chemicals and therefore not subject to review.

Dr. AUER: Well, no. Actually, you've got the statistics a little off there.

Dr. DAVIES: I'd welcome...

Dr. AUER: Sure.

Dr. DAVIES: ...but since you don't know what are nanomaterials...

Dr. AUER: But we do. We do, Terry. We do. Any time we receive a new chemical notification on a material that appears to be nanosized, we ask the notifier a series of questions so we can understand the size range, the presence of novel properties and so forth. Now, in our new chemicals experience, there was one notification for a nanoscale material, which clearly exhibited unique properties. For the other materials that were nanosized, they clearly were nanoscale materials, but they did not exhibit any unique properties.

Dr. DAVIES: We get to the key point here, because the question is what do you mean by properties. If we're talking about biological effects or how they're distributed in the environment, I do not believe that you can say that a nanosized piece of silver, let's say, behaves the same as an ingot of silver. The biological differences are significant and that means that the agency has to review it.

FLATOW: Mr. Davies, hang on, I'll give you a chance to reply. I have to just remind everybody that I'm Ira Flatow and this is TALK OF THE NATION: SCIENCE FRIDAY from NPR News.

Dr. AUER: Those are good points, Terry. And the size of the materials is certainly critical in assessing the exposure and the effects. The point that I was making is essentially recognizing that nanoscale materials have been around for millennia. There's a published paper where the carbonaceous material in Damascus swords was actually carbon nanotubes from whatever 2,000 years ago.

The point I'm making is that there are a number of things that are small in size. We've been using them in technology for many years. Fumed silica is an example of that. We assess those materials, considering them to be more common to traditional chemicals than to something which embodies all of the elements of nanotechnology. We are particularly alert to any nanoscale materials that demonstrate an ability to exhibit unusual or novel properties and would then ask the appropriate questions to understand those materials as needed.

FLATOW: You know, lead has been around forever, but the Romans had no idea it was going to kill them.

Dr. DAVIES: Exactly.

Dr. AUER: Well, that is true. But a lot of understanding has developed over time. And I think the research efforts which are growing, the in-depth program which will develop basic and detailed information on these materials, as well as an international collaboration to develop a foundation data set on representative nanomaterials, I believe, will speed the development of the data which are necessary to provide for a sound, scientific assessment basis.

FLATOW: I have a - just a couple of minutes. Dr. Davies, you say that the voluntary program is not adequate. What would be an alternative to volunteer?

Dr. DAVIES: An alternative would be to use the Toxic Substances Control Act to require that nanomaterials be submitted under the new chemical provisions of the act. And I think you can do that, and have EPA review nanomaterials for their health and safety effects before you can put them on the market.

FLATOW: Any problem? Mr. Auer, any problem with that? I'm waiting for you react. I guess I have to prod you a little bit.

Dr. AUER: Well, I think the approach that we've outlined provides a thoughtful and expeditious approach to develop the understanding and obtain needed oversight. If we were to attempt to do this under regulatory measures only, I think it would take number of years to develop and implement those measures. We actually lack the kind of understanding which is needed to provide a thoughtful and informed approach. The stewardship program plus the other work will provide that understanding. And if regulatory measures are needed in the future, we will take those acts.

FLATOW: I gave Mr. Auer first words. Dr. Davies, you get the last word. I have 30 seconds.

Dr. DAVIES: Okay. I think that nanotechnology is a wonderfully promising technology. And, in part, to guarantee that the public doesn't react against it, we need a regulatory oversight system. We need something that protects the American public from any potential health or environmental effects, and you're not going to do that on a voluntary basis.

FLATOW: All right. Well, hopefully, big technology. We will continue watching this story. Thank you, Dr. Terry Davies, senior advisor to the Project on Emerging Nanotechnologies at Woodrow Wilson International Center for Scholars. Charles Auer, technical director of the Nanoscale Materials Stewardship Program at the EPA in Washington. Thank you for taking time to be with us.

Dr. DAVIES: Thank you, Ira.

Dr. AUER: Thank you for this opportunity.

FLATOW: You're welcome. Have a good weekend.

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