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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."

54 comments

  1. "Nanotechnology", bah! by Animats · · Score: 3, Insightful

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

    1. Re:"Nanotechnology", bah! by The+Great+Pretender · · Score: 2, Interesting

      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.

      --
      A positive attitude may not solve all your problems, but it will annoy enough people to make it worth the effort.
    2. Re:"Nanotechnology", bah! by andywills · · Score: 2, Interesting

      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

  2. too broad by TheSHAD0W · · Score: 4, Insightful

    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".

    1. Re:too broad by QuantumG · · Score: 1

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

      --
      How we know is more important than what we know.
    2. Re:too broad by Harmonious+Botch · · Score: 1

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

    3. Re:too broad by QuantumG · · Score: 1

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

      --
      How we know is more important than what we know.
    4. Re:too broad by LifesABeach · · Score: 1

      '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

    5. Re:too broad by hcob$ · · Score: 1
      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.
      --
      Cliff Claven
      K.E.G. Party Chairman
      Founding Leader of: Koncerned for Egalitarin Governance
    6. Re:too broad by Anonymous Coward · · Score: 0

      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!!!!!

  3. What worries is me by XNine · · Score: 3, Interesting

    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.

    --
    Never monkey with another monkey's monkey.
    1. Re:What worries is me by Anonymous Coward · · Score: 1, Insightful

      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.

    2. Re:What worries is me by Anonymous Coward · · Score: 0

      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.

    3. Re:What worries is me by megaditto · · Score: 1

      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 biologists can make at whim :)
      Use of these has been approved by the FDA!

      --
      Obama likes poor people so much, he wants to make more of them.
    4. Re:What worries is me by Harmonious+Botch · · Score: 4, Funny

      "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.

    5. Re:What worries is me by SinGunner · · Score: 1

      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.

    6. Re:What worries is me by ozmanjusri · · Score: 1
      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.

      --
      "I've got more toys than Teruhisa Kitahara."
  4. Molecular Manufacturing by QuantumG · · Score: 1

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

    --
    How we know is more important than what we know.
    1. Re:Molecular Manufacturing by TheSHAD0W · · Score: 1

      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.

    2. Re:Molecular Manufacturing by DarrylKegger · · Score: 1

      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.

  5. Note by maynard · · Score: 3, Interesting

    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.

    1. Re:Note by Anonymous Coward · · Score: 3, Interesting

      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.

    2. Re:Note by suntac · · Score: 1

      "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

      --
      Regards, Johan Louwers.
    3. Re:Note by maynard · · Score: 1

      What an amazing reply! Thank you so much for offering your insider's perspective!

  6. Post nano11 world by From+A+Far+Away+Land · · Score: 2, Insightful

    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.

    1. Re:Post nano11 world by ocelotbob · · Score: 1

      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.

      --

      Marxism is the opiate of dumbasses

    2. Re:Post nano11 world by RexRhino · · Score: 1

      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!

  7. 20% seems high by enronman · · Score: 1

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

    1. Re:20% seems high by brusk · · Score: 3, Informative

      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%.

      --
      .sig withheld by request
    2. Re:20% seems high by ChaosWeevil · · Score: 2, Informative

      How much do you spend on food/medications?

      I think the amount might be higher than you think.

    3. Re:20% seems high by Harmonious+Botch · · Score: 1

      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.

  8. MS by Lord+Ender · · Score: 1

    Since when did the FDA have anything to do with materials science? I thought they were about drugs and food.

    --
    A slashdotter who didn't build his own computer is like a Jedi who didn't build his own lightsaber.
    1. Re:MS by mikesd81 · · Score: 1

      Well imagine it used for diseases such as cancer? It could turn into a surgical tehnique of some sort.

      --
      That which does not kill me only postpones the inevitable.
  9. What's all the paranoia for? by DoubleRing · · Score: 4, Insightful

    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.

    --
    Before you die, you see DoubleRing...
  10. A bit much by TubeSteak · · Score: 4, Funny

    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.

    --
    [Fuck Beta]
    o0t!
    1. Re:A bit much by MrSteveSD · · Score: 1

      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.

  11. Here's something worth reading by cy_a253 · · Score: 2, Informative

    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

  12. Hey FDA... Resistance is futile! by __aaclcg7560 · · Score: 3, Informative

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

  13. Nanotech Nonsense by Alchemist253 · · Score: 3, Informative

    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.

    1. Re:Nanotech Nonsense by belg4mit · · Score: 1

      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].

      --
      Were that I say, pancakes?
  14. Think outside the vat. by tempest69 · · Score: 1
    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

  15. Nanotech by Sproggit · · Score: 1

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

    Well, SOMEONE had to say it.

    1. Re:Nanotech by denebola · · Score: 1

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

      Rings too true for me.

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

  16. MOD PARENT UP -- lot of info there, despite AC by Anonymous Coward · · Score: 0

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

    It's full of useful information though.

  17. FDA? by Anonymous Coward · · Score: 0

    FDA can go Fuck Dat Ass!

  18. PROVEN FACT ! Buckballs cause retardation in brain by Anonymous Coward · · Score: 0

    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.

  19. Online references defining Nanotechnology by Morgaine · · Score: 3, Informative

    >> 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.

    --
    "The question of whether machines can think is no more interesting than [] whether submarines can swim" - Dijkstra
  20. It is not possible to regulate MNT by Morgaine · · Score: 1

    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.

    --
    "The question of whether machines can think is no more interesting than [] whether submarines can swim" - Dijkstra
  21. Nano Software EULA by Deliveranc3 · · Score: 3, Funny

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

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

  22. Industrial Nanorobotics by SMACX+guy · · Score: 1

    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?

  23. nanoparticles behave differently than non-nano. by Vellmont · · Score: 2, Informative

    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?

    --
    AccountKiller
  24. This was discussed in early nano work. by Ungrounded+Lightning · · Score: 1

    ... 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.")

    --
    Bantam Dominique roosters crow a four-note song. Once you've heard it as "Happy BIRTHday" you can't NOT hear it that way