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."

Comments

"Nanotechnology", bah!

[Animats]

This business of calling surface chemistry of finely divided powders "nanotechnology" is a bit much.

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

too broad

[TheSHAD0W]

The term "nanotechnology" is much too broad. Let's use "nanoscale materials" for this sort of thing, and "nanomechanics" for what all us /.'ers think when we hear "nanotechnology".

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.

Re:What worries is me

[Harmonious Botch]

"IS how the tech is going to be implemented. How will the nano-machines know what to do?"

They will run Windows Nano. When it crashes, you will turn blue.

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.

Post nano11 world

[From A Far Away Land]

In a world where the EPA let firefighters clean up toxic carcinogenic nano-particle riddled debris after the WTC towers left smashed asbestos dust on all surfaces, I really don't trust the FDA with my life. Government will do what is expedient, not what is in the best interest of health based on scientific or even logical reasoning.

Re:20% seems high

[brusk]

1. You eat, presumably? Maybe drink? That's the FDA's bailiwick. Spending on food is ~13% of household income in the US (http://www.bls.gov/opub/ted/2006/may/wk4/art05.ht m)
2. You're not an old person, probably, so you don't take lots of drugs. But many do.
3. You're not a drug addict, probably, so you don't take lots of drugs. But many do.
Add up the above and you easily get 20%.

What's all the paranoia for?

[DoubleRing]

It's not like we haven't been exposed to nanoparticles all the time. Just set a stick on fire. Right before your eyes, thousands of nanoparticles are being created. If you examined the soot, you'd find buckyballs and tubes. And when you smell smoke, OMG, you're inhaling nanoparticles! Plus, your body even has the ability to deal with self-replicating invasive nanoparticles (technically they are not "alive).

Well, I guess we shouldn't go barreling blindly though, we don't want another asbestos.

A bit much

[TubeSteak]

Even more so is when you get past the marketing-speak and read their literature, only to discover that some products being pushed aren't nano-anything.

nano = 1x10^-9
micro = 1X10^-6

A surprising number of companies try to sex up their micron technology with the prefix nano.

Re:20% seems high

[ChaosWeevil]

How much do you spend on food/medications?

I think the amount might be higher than you think.

Here's something worth reading

[cy_a253]

This is a great all-around introduction to real "nanotech", it's the entire book online, for free.

http://www.foresight.org/UTF/Unbound_LBW/index.htm l

Hey FDA... Resistance is futile!

[__aaclcg7560]

All the FDA has to do is watch Star Trek to understand that nanotechnology is very bad for humans.

Nanotech Nonsense

[Alchemist253]

As I have repeatedly said before, the whole "nanotech" craze is a bunch of marketing baloney.

Know how long a typical C-C bond in an organic molecule is? Hint: try wikipedia. It doesn't take very many atoms to make a single molecule a "nanoparticle!"

My fellow chemists and I have been doing nanotech for years - that is what the FDA has spent all its existence reviewing! I have the utmost respect for those working on new engineered materials, etc., and am perfectly willing to let them call themselves "nanoengineers" instead of the older "material scientists" if it helps them get elusive grant money, but we can't start regulating gold nanoparticles or quantum dots any differently than we would, say, cisplatin.

There simply isn't any fundamentally different science going on in nanotechnology that isn't already present (albeit perhaps in a previously esoteric realm) in chemistry, materials science, or solid-state physics.

Online references defining Nanotechnology

[Morgaine]

>> This business of calling surface chemistry of finely divided powders "nanotechnology" is a bit much.

That's very true. I'll stick with the definitions given by the founder of the field (ie. Drexler), as it's less subject to commercial and political manipulation. Much of the defining material is freely available online, for anyone who wants their information from the horse's mouth.

First of all there's the online version of Eric Drexler's extremely seminal Engines of Creation. It's a fantastic read, even after all these years.

(The online version of EoC used to be maintained at the Foresight Institute, but it's now kept by Drexler himself above. His whole site is a great resource of course, so clear out the tail of the URL and have a look around.)

Then there's the online version of the popular Unbounding the Future, an easily readable and slightly updated introduction to nanotechnology for everyone, although somehow I find it lacks the charm of Engines of Creation.

But nothing beats his textbook Nanosystems though. This book is a 150% must-have for anyone with a strong interest in nanotechnology, because even if you cannot follow the detailed science and mathematics, the diagrams and tables alone justify the cost.

Unfortunately the online version of Nanosystems is still at a very early stage, and is not really useful except as an online table of contents. Buy the textbook, you won't regret it.

Nano Software EULA

[Deliveranc3]

1. Nanobots will not recycle your tissue to create more Nano bots.

2. We reserve the right to change this agreement at any time.

nanoparticles behave differently than non-nano.

[Vellmont]

It's not exactly paranoid here. It's a well reasoned and cautious approach that we haven't tested these new nano-particles as food additives, drugs, etc. If they didn't behave any different from the much larger sized particles, then why are companies interested in them?

There's nothing inherently dangerous about nano-particles, just like there's nothing inherently dangerous about chemicals. It's simply the fact that nano-scale implementations of old substances haven't been tested, and behave differently. Why is that so difficult for some people to understand?