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FDA Gets Mixed Advice on Nanotechnology

samzenpus posted more than 7 years ago | from the better-living-through-small-machines dept.

54

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."

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54 comments

"Nanotechnology", bah! (3, Insightful)

Animats (122034) | more than 7 years ago | (#16403493)

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

A bit much (4, Funny)

TubeSteak (669689) | more than 7 years ago | (#16403947)

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:A bit much (1)

MrSteveSD (801820) | more than 7 years ago | (#16410165)

Drexler really pioneered the whole idea of nanotechnology yet he has been sidelined and the term has has now be hijacked by people who want to funnel money into their own companies.

Online references defining Nanotechnology (3, Informative)

Morgaine (4316) | more than 7 years ago | (#16405843)

>> 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 [e-drexler.com] . 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 [foresight.org] , 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 [amazon.com] 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 [foresight.org] 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.

Re:"Nanotechnology", bah! (2, Interesting)

The Great Pretender (975978) | more than 7 years ago | (#16406349)

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! (2, Interesting)

andywills (306560) | more than 7 years ago | (#16406513)

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 (4, Insightful)

TheSHAD0W (258774) | more than 7 years ago | (#16403549)

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".

Re:too broad (1)

QuantumG (50515) | more than 7 years ago | (#16403683)

Molecular Manufacturing is the term I've heard bantered around to mean any nanotechnology that includes assemblers.

Re:too broad (1)

Harmonious Botch (921977) | more than 7 years ago | (#16403937)

Call it "nano-inteligent design". That may give it a better chance than "stem cell research" had.

Re:too broad (1)

QuantumG (50515) | more than 7 years ago | (#16403963)

ironically, the religious right are only happy for super-intelligences to design life.

Re:too broad (1)

hcob$ (766699) | more than 7 years ago | (#16406603)

ironically, the religious right are only happy for super-intelligences to design life.
*hands Quantum a Special Broom*

Next time you want to make one of "those" generalilzations, I recommend you use this broom.

Re:too broad (1)

LifesABeach (234436) | more than 7 years ago | (#16404157)

'The FDA wants to learn of new and emerging science issues related to nanotechnology, especially in regard to safety,'

The FDA could make it mandatory to read /.

"Slowly, one by one, the penguins steal my sanity." - Unknown

Re:too broad (0)

Anonymous Coward | more than 7 years ago | (#16408909)

Shouldn't the FDA only be concerning itself with things that involve Food or Drugs?? Yes, I know a lot of nanotech will be involved in those industries, but it is sounding like that want the overall authority for anything termed 'nanotech', even in industries it has no business touching.

Only things that come to mind right now are reactor bioproducts, sewage decomposition, etc... I'm sure there is a host of others out there that I don't know about, but I have to wonder if the FDA is going for a power grab here??

Does the FDA really have their shit together that they could handle the ethic, moral, economic, human, environmental implications that might crop up with this developing field?? If the past 10 years of FDA approved meds and scandals has shown anything, my bet is not!!!!!

What worries is me (3, Interesting)

XNine (1009883) | more than 7 years ago | (#16403607)

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 (1, Insightful)

Anonymous Coward | more than 7 years ago | (#16403649)

None of this will be relevant for decades. Nanotech today (except for these surface chemistry guys) amounts to nothing more than glorified MEMS (i.e., dirty CMOS) processing. These nanomachines you worry about are a long way off.

Re:What worries is me (0)

Anonymous Coward | more than 7 years ago | (#16403697)

Read THESHADOW's post above, this exactly what he was referring to.

What the FDA is talking about here is not nanomachines but rather custom engineered nanoscale materials. The term nanotechnology is just way too overloaded.

Re:What worries is me (1)

megaditto (982598) | more than 7 years ago | (#16403717)

How do cells in your body know "what to do"? How do viruses know which cells to kill? All the future nanotechnology research will be built upon what biologists already know today about things such as bacteriophages, flagella, ribosomes, etc. These have worked for billions of years rather well.

Check out a pic of a nanometer-scale killing machine [wikipedia.org] biologists can make at whim :)
Use of these has been approved by the FDA!

Re:What worries is me (4, Funny)

Harmonious Botch (921977) | more than 7 years ago | (#16403867)

"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.

Re:What worries is me (1)

ozmanjusri (601766) | more than 7 years ago | (#16404943)

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

Yeah, and it'll be so bloated you'll need a microprocessor to run it.

Re:What worries is me (1)

SinGunner (911891) | more than 7 years ago | (#16404055)

How did this get modded "interesting"? Who here actually thinks "nano-machines" are "machines" as we know them? Don't worry kiddo, those nano-machines will get nano-norton installed on the right quick and then you'll just have to nano-update it every few nano-weeks.

"Commanding" "nano-machines"... Now I've heard everything.

Industrial Nanorobotics (1)

SMACX guy (1003684) | more than 7 years ago | (#16407433)

Already we have turned all of our critical industries, all of our material resources, over to these .. things .. these lumps of silver and paste we call nanorobots. And now we propose to teach them intelligence? What, pray tell, will we do when these little homunculi awaken one day and announce that they have no further need of us?

Molecular Manufacturing (1)

QuantumG (50515) | more than 7 years ago | (#16403661)

I wonder if we'll see an actual assembler in my lifetime. Even a hydrocarbon only assembler seems unlikely.

Re:Molecular Manufacturing (1)

TheSHAD0W (258774) | more than 7 years ago | (#16403711)

One can only hope. We have most of the technology to build one; all that's left is some way to hold the atoms that are moved into position in place until the structure is complete, and, of course, a good science of how atoms interact at such a scale.

Re:Molecular Manufacturing (1)

DarrylKegger (766904) | more than 7 years ago | (#16404671)

and, of course, a good science of how atoms interact at such a scale.

it's called quantum mechanics. The obstacles in nanotechnology are mostly engineering ones rather than basic science.

Think outside the vat. (1)

tempest69 (572798) | more than 7 years ago | (#16404787)

Depends on what your willing to call an assembler.. For the most part molecular biology is able to make some pretty small stuff. So with some enzymes glucose and UTP can be used to polymerize into glycogen chains, the mix of branching enzymes can change the structure. Glucose could also polymerize into cellulose with alternate enzymes. These are reasonably workable in a vat.. whereas with Genetic Tampering you can manage to make a goat that has spider silk protein in her milk. (skip that goat cheese pizza), but then youve crossed that line of being "out of the vat". So quite a bit of nano-tech is available as long as you think outside the vat

Even in the vat there is a ton of stuff from a chemical, point of view

Storm

Note (3, Interesting)

maynard (3337) | more than 7 years ago | (#16403703)

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 (3, Interesting)

Anonymous Coward | more than 7 years ago | (#16404525)

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.

MOD PARENT UP -- lot of info there, despite AC (0)

Anonymous Coward | more than 7 years ago | (#16405373)

It's not me, but I have no way of proving that. :P

It's full of useful information though.

Re:Note (1)

suntac (252438) | more than 7 years ago | (#16405187)

"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."

It is a good thing they keep a close look at anything that is ingested. However they should also keep a close look on all nano tech that is leaving the laboratory and is coming into the world. The consequences if things get wrong are just to big to get sloppy with it.

Regards,
Johan Louwers

Post nano11 world (2, Insightful)

From A Far Away Land (930780) | more than 7 years ago | (#16403707)

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:Post nano11 world (1)

ocelotbob (173602) | more than 7 years ago | (#16403853)

Perhaps it's just a different philosophy of life, but I'd rather die young due to a technological advance gone awry than live until I'm 80 in some stagnant cesspool because people are too risk-adverse to allow change.

Re:Post nano11 world (1)

RexRhino (769423) | more than 7 years ago | (#16412107)

You don't trust the FDA with your life? The Government will do what is expedient and not what is in the best interest of health? Couldn't agree with you more! Dictatorships never work. Lets abolish the FDA, and let people get information from a whole variety of different sources, and let them make personal health decisions themselves!

20% seems high (1)

enronman (664750) | more than 7 years ago | (#16403715)

20% of my spending is for FDA regulated products? Hell NO!

Re:20% seems high (3, Informative)

brusk (135896) | more than 7 years ago | (#16403857)

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 [bls.gov] )
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%.

Re:20% seems high (1)

Harmonious Botch (921977) | more than 7 years ago | (#16404191)

I fear that you may have misread TFA, or misread GP. The question is not what percentage of spending is under the jurisdiction of the FDA, it is what percentage of spending is under the jurisdiction of the FDA and is nanotech ( or at least claimed to be ). I think GP has a fair question.

Re:20% seems high (2, Informative)

ChaosWeevil (1004221) | more than 7 years ago | (#16403975)

How much do you spend on food/medications?

I think the amount might be higher than you think.

What's all the paranoia for? (4, Insightful)

DoubleRing (908390) | more than 7 years ago | (#16403939)

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.

nanoparticles behave differently than non-nano. (2, Informative)

Vellmont (569020) | more than 7 years ago | (#16411373)

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?

Hey FDA... Resistance is futile! (3, Informative)

creimer (824291) | more than 7 years ago | (#16404221)

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

Nanotech Nonsense (3, Informative)

Alchemist253 (992849) | more than 7 years ago | (#16404355)

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 [wikipedia.org] . 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 [wikipedia.org] .

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.

Re:Nanotech Nonsense (1)

belg4mit (152620) | more than 7 years ago | (#16404741)

Exactly, marketing. You argue that there's nothing fundamentally different in the science
(declaring oct-1,3,5-triene a nanomaterial), but it would seem to me there is. There is a
difference between small and medium organic compounds and nanoparticles of "metals"*,
"ceramics", etc. 1) Obviously there is a difference in properties between nano and bulk,
otherwise there would not be interest in studying them. 2) Their biological activity is
incredibly different. Compare bulk quartz to the dust which causes silicosis, or the
difference between PM10 and PM2.5 Finally, I'm not certain cisplatin is the best example
given it's relative newness.

The question is not about the science, or rather the use in laboratories. Rather, it's about
the mass production and marketing of untested substances. Granted, a large part of the
compounds produced by DOW et al. also escape rigorous testing. Compare and contrast GMOs.

*Quoted because well, at that size it's hard to exhibit many of the properties characteristic
of these classes of compounds, but I repeat myself [that's the whole point].

Nanotech (1)

Sproggit (18426) | more than 7 years ago | (#16405337)

I, for one, welcome our new nano-enhanced overlords.

Well, SOMEONE had to say it.

Re:Nanotech (1)

denebola (868771) | more than 7 years ago | (#16405881)

I, for one, welcome our new nano-enhanced overlords.

Rings too true for me.

I'd rather a 'softly, softly' approach with nanotech.

FDA? (0)

Anonymous Coward | more than 7 years ago | (#16405447)

FDA can go Fuck Dat Ass!

PROVEN FACT ! Buckballs cause retardation in brain (0)

Anonymous Coward | more than 7 years ago | (#16405579)

PROVEN FACT ! Buckballs cause retardation in brain, inhaled merely via the nose! (or inhaled in gills in fish)

incredibly small amounts of nano-carbon tech can devastate countless brains rapidly, in an unknown effect, as horrifying as a catayst reaction of some sort.

NANO TECH DETROYS IQ!

it is established fact backed by research

NANO carbon needs to stay out of all facets of human experience until it is regulated carefully from ruining the brains of millions.

Remember the FCC (0)

WisC (963341) | more than 7 years ago | (#16405961)

I hope the FDA does not get their hands on this technology, imagine organic censors built into every kind of broadcast device, they could even have a special edition for the superbowl. Could be a nice slashdot edition, it could limit the ingestion of cheetos and the spewing of drivel about the joys of opensource

It is not possible to regulate MNT (1)

Morgaine (4316) | more than 7 years ago | (#16406561)

Others have pointed out the intentional messing up of definitions of "Nanotechnology" to suit the vested interests, so I won't address that. Suffice to say that any current or envisaged regulation concerns only nanoscale materials, and not molecular nanotechnology (MNT) which is the original "Nanotechnology" as defined by Drexler.

What I will address is regulation of MNT (once it exists). In a nutshell, you can't.

The basic reason is simple: MNT will be a kitchen sink manufacturing technology (ie. do it at home with no special ingredients other than dirt, water, and air for carbon from CO2), and a microdot seeding technology (eg. carry the precursor factories on an invisible dot on your watch, say). So, you won't be able to stop it by restricting ingredients, nor by external monitoring.

As a result, the only way in which MNT could be regulated is by flooding the world with even more nanomachines to monitor everything that is going on --- in other words, a fully invasive world police state.

Furthermore, it would have to be a WORLD police state, because any invasive regulation done purely at home would achieve nothing, other than ensure that the rest of the world takes the lead in MNT.

This is why regulation of MNT makes no sense at all. The only way to avoid the undoubted dangers of MNT in the hands of nasty people is by defense. No, not the kind of defense where you bomb others, but the real kind, wrapping yourself and your community in a shield.

That will be extremely difficult. Nevertheless, it is the only way, and we ought to start planning for it.

This was discussed in early nano work. (1)

Ungrounded Lightning (62228) | more than 7 years ago | (#16413533)

... the only way in which MNT could be regulated is by flooding the world with even more nanomachines to monitor everything that is going on --- in other words, a fully invasive world police state

This was discussed even in the very early days of nanotech theorizing. It was called the "Blue Goo" scenario - one of the possible ways of heading off the "Grey Goo" scenario.

The latter is where unbounded replicators get out of hand, turn EVERYTHING into more of themselves. Potentially a few get picked up by solar wind and carried to other planets, solar systems, and galaxies, where they do the same. Some consider this even worse than the mere total extinction of Earth-origin life (excluding the wild replicators), because the replicators could (and likely would) have been designed with enough error-checking and redundancy that they wouldn't evolve into anything else, and would likely kill off any other life as well, with the result that "Nothing else interesting happens for the rest of time.")

Nano Software EULA (3, Funny)

Deliveranc3 (629997) | more than 7 years ago | (#16407011)

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

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