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FDA Asked to Regulate Nanotechnology

WillAffleckUW writes "According to the Washington Post, a coalition of environmental and consumer groups has asked the FDA to look at regulating nanotechnology. They point out that there are more than 100 nanotechnology products and that nanoparticles can penetrate cells and tissues, migrate through the body and brain and cause biochemical damage."

22 of 248 comments (clear)

  1. From the Article by Orrin+Bloquy · · Score: 4, Funny

    "Concerned buckyball-momites asked, 'won't someone think of the chelates?'"

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  2. Oh Gawds... by duerra · · Score: 5, Insightful

    How about the FDA regulate... food and drugs? This is kind of broad, don'tcha think? I mean, jeez, "nanotechnology" encompases a whole load of things that have absolutely nothing to do with the FDA, including the equipment that I'm writing this message with, and the equipment you're reading this with. Hell, why not ask the FCC to regulate nanotechnology. It would make just as much sense. Or the Department of Homeland Security. Or any other government bureaucracy with interests to protect.

    Or better yet, how about the government just stay the eff out of things for a change and let's see what happens, and deal with issues as they arise? That would be a novel idea, wouldn't it? The last thing I need is the FDA telling me I can't buy the latest and greatest geeky ballpoint pen because the ink might be poisonous - or, god forbid, get me high.

    Of course, maybe TFA just failed to mention that they only wanted things that actually deal with F&D regulated. I guess neither would surprise me at this point.

    1. Re:Oh Gawds... by Quaoar · · Score: 4, Insightful

      Well, to be fair, what department WOULD regulate nanotechnology? I mean it's quite new, and has applications in MANY areas, including foods and drugs. Someone's going to regulate it eventually. I mean, congress COULD directly pass laws to regulate it, but that seems far less friendly to industry.

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    2. Re:Oh Gawds... by duerra · · Score: 4, Insightful
      Well, to be fair, what department WOULD regulate nanotechnology? I mean it's quite new, and has applications in MANY areas, including foods and drugs. Someone's going to regulate it eventually. I mean, congress COULD directly pass laws to regulate it, but that seems far less friendly to industry.


      Once you realize that "nanotechnology" plays a part in almost every part of your daily life, from the clothes you wear, to the wheels your car rides on, to the TV you watch, to, well... you get my drift.

      Nanotechnology isn't some tangible thing to be regulated. It's a word that encompases a part of almost everything in our lives, because it is, simply put, technology on a small scale. If this article is accurate, this petition was submitted out of pure ignorance.
    3. Re:Oh Gawds... by kfg · · Score: 4, Insightful

      Well, to be fair, what department WOULD regulate nanotechnology?

      What department regulates gelatin intended for human consumption?

      That's right, the FDA.

      What department regulates glue, leather and violin strings?

      Not the FDA.

      How about we let the relevant agencies regulate within the sphere of their mandate and expertise? And God forbid that should leave certain applications beyond the realm of the government. I really don't feel like having to bring my fiddles to some sort of inspector other than my customers, nor do I see any value in it.

      KFG

    4. Re:Oh Gawds... by vux984 · · Score: 5, Insightful

      True, however, the reach of the FDA *is* surprisingly broad. For example contact lenses and tampons are regulated by the FDA ... and they are neither food nor drugs.

      Similiarly the FDA's scope reaches into approving materials (e.g. plastics) and so forth that might be used in the packaging of food or drugs, or even used in the presence of food or drugs, or even used in a facility where packaging of food or drugs is taking place.

      e.g. the FDA would be interested in the presence of asbestos in a facility that makes the plastic used in the packaging of tampons. (which again are neither food nor drugs).

      Anyhow, with that kind of scope its reasonable to be watching for 'harmful' elements in clothing and wheels -- as these shirts and wheels might be on staff or forklifts in facilities that manufacture or transport food and drugs...

      Once you realize that "nanotechnology" plays a part in almost every part of your daily life, from the clothes you wear, to the wheels your car rides on, to the TV you watch, to, well... you get my drift.

      If by getting your drift you mean that evidently the FDA also plays a part in almost every part of your daily life. ;)

    5. Re:Oh Gawds... by ScoLgo · · Score: 5, Funny

      "Lets just create the Department of Nanotechnology..."

      The only thing I like about that idea is the resulting acronym...

      (D)epartment (O)f (N)ano(T)echnology

      --
      "Michael, I did nothing. I did absolutely nothing - and it was everything that I thought it could be."
    6. Re:Oh Gawds... by dbrower · · Score: 4, Insightful
      RTFA. The suit "petitioned the Food and Drug Administration yesterday to beef up its regulation of nanoparticle-containing sunscreens and cosmetics and recall some products." These are things over which it already has jurisdiction.

      This is NOT a request for blanket regulation, as some of the more knee-jerk replies suggest.

      -dB

      --
      "It if was easy to do, we'd find someone cheaper than you to do it."
    7. Re:Oh Gawds... by syphax · · Score: 3, Insightful

      From TFA:

      Among the FDA-regulated products being sold are sunscreens containing titanium dioxide or zinc oxide nanoparticles (which offer strong ultraviolet protection while remaining colorless) and cosmetics with nanoscale liposomes -- tiny chemical bubbles that deliver moisteners and other ingredients to the skin.

      They are asking for better regulation of currently-regulated products. Seems pretty in-scope to me.

      Or better yet, how about the government just stay the eff out of things for a change and let's see what happens, and deal with issues as they arise? That would be a novel idea, wouldn't it?

      Yeah, that approach carries no risks.

      Is it possible that it makes more sense to conduct controlled trials with a limited number of subjects, rather than poorly controlled trials with possibly millions of subjects? That the risk of harm of the latter case might be significant?

      I submit that regulation of something with plausible but poorly understood impacts on human and/or enviromental health may not be a terrible idea. The problem, of course, is that it's really hard to write regulations that achieve their ends without being painfully burdensome for the regulated. This is partly due to having to loophole-proof the regs, as history has shown that regulated parties are really good at meeting the letter of the law while butchering the spirit. Also, not all regulations have sucked: from what I can tell, SO2 trading, which has a specific target but allows flexible, market-based solutions, basically works.

      --
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    8. Re:Oh Gawds... by Ohreally_factor · · Score: 4, Interesting

      As far as the Gray Goo threat goes, I don't think it's the immediate concern here.

      Quite frankly, given the irresponsible extreme anti-regulation attitudes expressed by many here, I think I am in favor of a specific regulatory agency, such as we have for nuclear power.

      There are too many technologists (or people who think they are) that are all too willing to play fast and loose, without an understanding, let alone a regard, for the consequences of their actions. Too many companies that would put short term profit ahead of the general public's welfare.

      Regulation of nanotechnology is a no-brainer.

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      It's not offtopic, dumbass. It's orthogonal.
  3. An excellent way to get nothing done! by FooAtWFU · · Score: 3, Insightful

    This is probably going to end up as an excellent way to make sure that no one bothers to do nanotechnology research in the United States.

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  4. and they say "Shure!" by way2trivial · · Score: 3, Insightful

    and ask for a trillion more a year, to regulate and enforce limits on a fast breaking technology, but only when done in the USA, meaning everyone cutting edge, or sloppy, or lazy, or with imperfect tools, starts working outside the USA, blunting the edge of this countries technological advantage a little more-- and when a self-replicating oil eating VonNeumann get's loose, anyone who might have had the skills to defeat the new micro-overloads will have never developed said skills, as they had to expend too much frustration/energy/life forces learning about red-tape processes.

    --
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    1. Re:and they say "Shure!" by DougLorenz · · Score: 3, Informative

      There is a major difference between nanoparticles and self-replicating nanobots...

      People who are afraid that minature killer robots are going to wipe out humanity should dial back the amount of time they spend watching the SciFi channel...

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  5. Remember Kids by youngerpants · · Score: 5, Funny

    Only you can prevent Grey Goo

  6. Progress! by thefirelane · · Score: 4, Insightful
    We used to just regulate things that caused problems

    Now we want to regulate things that could cause problems

    Hopefully, in the future we'll regulate things that could lead to technology that could cause problems.

  7. How to kill nanotech in its infancy... by kcbrown · · Score: 5, Interesting
    If you want to kill off an industry, the best way to do so is to regulate it the way the medical industry and the aviation industry are regulated.

    In both cases, the industry in question is regulated not at the results level but at the process level. To change the way an airplane is manufactured, you have to get your manufacturing process recertified by the FAA. It's a great way to prevent technological progress. To put this into perspective, modern piston airplanes are still using mechanical fuel injection. We're talking technology that was first put into use in the 1950s.

    As a result, it takes the financial commitment of basically building an entirely new company in order to manufacture composite airplanes (as opposed to using aluminum sheetmetal and rivets). Manufacturers aren't allowed to truly compete with each other by continuously improving their products in meaningful ways because the cost of improving the product is too high. Everything has to be recertified when a real improvement is made.

    And the same is true for medical equipment, which is one of the big reasons your out of pocket expense for a simple MRI session is several thousand dollars.

    So if we want to make sure that the U.S. is dead last in nanotech, the best way to do it is to regulate it the way we regulate medical equipment and aviation.

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    1. Re:How to kill nanotech in its infancy... by kcbrown · · Score: 3, Interesting
      I suppose I should mention an example of how to regulate an industry properly: the NHTSA.

      Automobile manufacturers don't have to get their manufacturing methods certified by the NHTSA. The NHTSA doesn't care how you manufacture something. It only cares about the end results: does the resulting product pass a battery of safety tests. If it passes, all is good.

      The end result is that auto manufacturers can continuously improve their product, as long as they continue to meet the result-oriented safety requirements of the NHTSA.

      That's the right way to regulate an industry: test for results, not processes.

      Needless to say, the FAA and the FDA don't do that, and you can see the difference in the costs and the quality.

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  8. The last thing Nanotechnology needs... by SFSouthpaw · · Score: 5, Funny

    is micro management.

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    ---southpaw
  9. Re:and they say "Shure!" or what's next by WillAffleckUW · · Score: 4, Insightful

    I know, I've sat in on about twenty nanotechnology seminars at the UW over the past six months.

    My point is, this is a real news story, the FDA has been asked by multiple groups to investigate nanotechnology for those products which may - or may not - be able to cross over into humans.

    Until they research it, they won't know if it's possible, and - if so - what safeguards or regulations are or should be necessary.

    At that point, after input from bioethicists - and I've attended a few panels and seminars on bioethics, as well as journal clubs - recommendations would be made and model legislation would be drafted.

    At that point, slashdotters would be able to publicly comment on any such proposed legislation.

    It's like when autos were invented - there were no traffic rules for a long time. Then, once they reached a certain level, people created regulations concerning driving, driving ages, rules of the road, railroad crossings, brakes, horns, and so on.

    Since we now have more than 100 nanotechnology patents, it's likely we are - in fact - at that point where we need to investigate whether or not we need regulations - and, if so, at what level. Perhaps we need such regulation at the creation side, perhaps at the manufacturing side, perhaps on the consumer side. We don't know yet.

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  10. Nanotech is more than tiny machines by TimmyDee · · Score: 5, Insightful

    Currently, many nanotech applications are in products (or proposed to be in products) that would come in direct contact with our bodies. Take sunscreen, for example. Some brands of sunscreen are being made with nanoparticles (thus making them nanotechnology) that can penetrate the blood-brain barrier. Do we have a clue what happens when those nanoparticles interact with our brain cells? Hell no! Has that stopped it from being on the market? Hell no!

    The issue at stake here is that we have a whole slew of products that have a significantly larger potential impact on our health. I'm not talking about the "smart" counter-top that will make plates out of itself just before dinner (although that would be cool -- I think Popular Science came up with that gem). I'm talking about practical applications of nanotech NOW. Nanoparticle sunscreen is just the first part. You'd better bet that the whole biomedical industry is looking into more advanced, more invasive nanotech applications. The jurisdiction would fall under the FDA sooner or later. Better sooner than later so they're not caught with their pants down.

    (I'm sure I'll get modded down for this one, but I think that we need to be cautionary to some degree. Otherwise we may have another DDT or thalidomide on our hands.)

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  11. A Study by Anonymous Coward · · Score: 5, Informative

    I know Slashdot likes to blindly bash things that might prohibit technological advance. But it's been said that the effects of nanotubes could be as dangerous as asbestos.

    Here's a study conducted by researchers from NASA, Wyle Labs, UofT Medical:

    http://toxsci.oxfordjournals.org/cgi/content/full/ 77/1/126

  12. Look into the Constitution by mangu · · Score: 3, Insightful
    Well, to be fair, what department WOULD regulate nanotechnology?


    The Constitution of the USA is very specific on exactly what the federal government can and cannot do. Among "internal" issues, i.e. everything that does not concern the relations of the USA with other countries, there is very little that the federal government has the authority to do, although no one would guess it from the way Washington acts.


    Unless someone finds a way to put nanotechnology in what has been used as the mother of all catchalls in Article I, section 8, "To regulate Commerce ... among the several states", I don't see much that the Congress of the USA can legislate about in nanotechnology.