FDA Gets Mixed Advice on Nanotechnology

mikesd81 writes, "There's an article at the Associated Press about how the government must balance close oversight of the fast-growing field of nanotechnology against the risk of stifling new development. Contrasting view came from a panel of experts brought together to discuss how nanotechnology should be regulated. The article states that submicroscopic particles are being incorporated in the thousands of products overseen by the FDA, including drugs, foods, cosmetics and medical devices and the products consist of roughly 20% of each dollar spent by U.S. consumers. Matthew Jaffe of the U.S. Council of International Business says, "The key is to use science to weigh both the benefits and the risks of nanotechnology. That's a balance the FDA already seeks to strike in assessing other products." From the article: "'The success of nanotechnology will rely in large part on how FDA plays its regulatory role,' said Michael Taylor of the University of Maryland's School of Public Health. The FDA doesn't believe nanotechnology is inherently unsafe, but does acknowledge that materials at the nano scale can pose different safety issues than do things that are far larger. 'The FDA wants to learn of new and emerging science issues related to nanotechnology, especially in regard to safety,' said Randall Lutter, the agency's associate commissioner."

What worries is me

[XNine]

IS how the tech is going to be implemented. How will the nano-machines know what to do? Through wireless signals? It sounds like a very insecure method to command the little things. Sure, they could potentially be used for extremely great things. But the risk is great too. Same they're killing cancer cells in some kids body. What happens if someone were able to reprogram them to kill other cells? Maybe I'm crazy, but I think the FDA and the developers/engineers REALLY need to have a good system in place for this before it ever takes off.

Note

[maynard]

The FDA is only concerned with nanotechnology that would be eaten, injected, used internally, or otherwise ingested. I don't believe they would have regulatory authority over nano-assembler use in manufacturing or environmental dumping. The EPA could possibly set regulations on the environmental aspects, and OSHA might be able to deal with the worker safety aspect of nantech used in manufacturing.

BTW: when does ordinary chip lithography become nanotech? I mean, isn't 45nm chip fab just around the corner? A good question to ask is whether regulating all nanotechnology makes sense, or if it is better handled by each respective regulatory agency. I would argue that too much centralization is probably a bad thing. Best to break the problem up and hand it out to the specialists within each field.

Re:Note

[Anonymous Coward]

I preface this by saying that I *actually* know quite a bit about this, knowing a number of the people involved with the proposal to the FDA. I'm also, well, a nanotechnologist in every sense of the word you could possibly think of, and know lots of people involved in startups centered around nanomaterials.

There are several interesting issues. The first is that nanotechnology is an absurdly easy field to get into. For instance, if you wanted to be a "nanotechnologist", all you need is a bottle of ferric chloride, ammonium hydroxide, citric acid, and some oil. Very cheap, and you could make a substance that's got a fairly significant market. The problem is that there is substantial evidence that the nanoscale foo is different in health effect than bulk foo. As a characteristic example, consider the ZnS nanoparticles you find in sunscreen. ZnS doesn't do much to you in bulk form, but in the nanoscale it could easily rupture cell walls. Or iron oxide --- in the bulk phase, it's basically completely inert, but in the nanophase it VERY rapidly catalyses the decomposition of H2O2. That catalytic ability probably exists in the bulk phase too, but the small surface area renders it irrelevant.

If the FDA were to from such evidence then say "nanoscale materials are DIFFERENT in properties from the same material in bulk, so they must all be approved from scratch before consumer use", those small businesses would be done for, and you'd end up with the biotech revolution all over again --- only the people who could afford the fees to get their materials approved would be able to operate. This pretty much would kill *every* nanotech startup out there. Many of these companies barely have the funding to hire enough employees to bring it to market, much less do rigorous health testing of every single material they make or use in the process.

So, it's a matter of cost/benefit. Obviously, the benefit of having nanotech in your computer chips (though hard drives have been sub-10nm in structure for a pretty long time, so really those are a better example) far outweighs the potential health hazards --- especially because the computer chip (and hard drive) are contained in packaging that is not intended to allow human exposure. It's sort of like those dessicator packets you get in your shoes --- it's packaged so that you don't eat it, so it's okay that it's not safe.

However, doing things like putting ZnS into sunscreen so that you don't look as pasty? That's a significantly harder benefit to justify an unknown health risk for.

It's a very tricky problem, and I'm not surprised the final version was mixed.

It should also be noted that they're not really talking about "nano-assemblers". They're talking about materials that are considered safe normally, which may become non-safe when they have surface areas like 100 m^2 / mg (which isn't unrealistic for nanomaterials). They're used everywhere already, we just don't know what kind of cancer they're giving us yet.

There is no well defined line between "normaltechnology" and "nanotechnology". It's fuzzy because there's no data yet on where properties start changing.

Leaving the decisions up to specialists is very tricky, because even the specialists have little data and no money to research every new nanomaterial. Right now there's a voluntary reporting system in place that's gotten a lot of good work done, but while obviously experts will make the end decisions, it's a question of whether you start from "not allowed" and prove it's safe, or start from "allowed" and wait for people to voluntarily demonstrate that their products are dangerous.

Re:"Nanotechnology", bah!

[The Great Pretender]

Having reviewed federal proposals in this area and knowing someone from the FDA advisory committee I can say that I don't see a huge push back on the scientific level of the use of the term nanotechnology in place of surface chemistry. Not only are the majority of uses for surface chemistry, but they also seem to be for Fe or TiO2 surface chemistry (the latter requiring some form of UV activation). To be brief there is simply money to be made from the product, but more depressing is that the scientific research community have embraced these definitions, as there is research funding to be gained using this particular buzz word. What could be worse than a scientific 'expert' claiming that a small zero valent Fe particle is nanotechnology just because they know the funding sorce will be favorable if they can claim they have funded X millions of total dollars in the fancy sounding nano-research arena. For those folks that say 'in general the reviewers should be knowledgable enough to be the first round of defence', no they are not.

Re:"Nanotechnology", bah!

[andywills]

Well, fine. Call it what you want. Did you know that the zinc oxide nanoparticles in sunscreen produce free radicals when they absorb UV light? That's something that the old white sunscreens (that used zinc oxide microparticles) didn't do. That's the general problem with nanotech--the same material can be inert or toxic depending on its size, method of preparation, etc. The FDA is currently set up to deal with distinct molecules, and they have to decide when a nanotech product counts as a "distinct molecule."

--A Nanoparticle Chemist