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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."
"Concerned buckyball-momites asked, 'won't someone think of the chelates?'"
"Made up/misattributed quote that makes me look smart. I am on
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.
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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.
The World Wide Web is dying. Soon, we shall have only the Internet.
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.
every day http://en.wikipedia.org/wiki/Special:Random
Products FDA Regulates
Food
Foodborne Illness, Nutrition, Dietary Supplements...
Drugs
Prescription, Over-the-Counter, Generic...
Medical Devices
Pacemakers, Contact Lenses, Hearing Aids...
Biologics
Vaccines, Blood Products...
Animal Feed and Drugs
Livestock, Pets...
Cosmetics
Safety, Labeling...
Radiation-Emitting Products
Cell Phones, Lasers, Microwaves...
Combination Products
Intron: the portion of DNA which expresses nothing useful.
Only you can prevent Grey Goo
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.
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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Considering nanotechnology is, so far, often just a fancy name for thin-film application of chemicals, of course it should be governed by the regulations applying to those chemicals. The FDA certainly has some say in that.
EVERYTHING is nanoparticulate in nature, including you. Just because these particles are being chopped up and misced better does not by any means imply that they are unhealthy. Your skin does a pretty good job protecting you from nanoparticulate oils and debris from bacteria. Just because there is better organization at the nano scale does not mean that the nano-particles will cause any sort of damage.
By placing a label on these products, consumers will irrationally be prejudiced against them. You should not do that to such a broad and beneficial industry. Mostly, these consumer groups do not understand the basic science. They just have a general technophobia and want to project that onto everyone else's lives.
Like anything, there should be health tests, but they should be data backed (as these are not). We can't assume that all these products are guilty until proven innocent.
We apologize for the inconvenience.
is micro management.
---southpaw
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.
-- Tigger warning: This post may contain tiggers! --
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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The FDA regulates (see their homepage) things marketted to treat and to prevent disease, generally, including both drugs and (though its not part of the name) non-drug biological products and medical devices (they also regulate food -- obviously -- cosmetics, animal feed and veterinary drugs, and radiation-emitting devices.) Nanotech is sometimes currently and quite likely more in the future applied to prevent and treat disease, and to that extent comes under the FDA's scope of responsibility, as either a "drug" or a "medical device", depending on how you look at it. Expanding their brief to explicitly include nanotechnology designed for use on or in the human body would make a lot of sense even if it isn't, per se, a "drug" or "medical device".
Well, nanotechnology is a pretty broad field.
The nanotechnology the article refers to is primary nanoparticles added directly to food and drugs, so it seems reasonable that the FDA might oversee this area. For instance, if they're putting nanoparticles into sunscreen or cosmetics made with Titanium or Zinc, then it seems reasonable that the FDA would make sure those are safe.
By design, nanoparticles are often far more reactive to surface chemistry than the same chemicals in other forms, so I'd want some regulations or at least basic studies. As the field evolves, there's also many very advanced medical applications for nanotechnology (such as tissue repair or targeted tumor attacks) that also should fall under their normal medical regulation and testing requirements.
That said, the FDA certainly doesn't need to regulate IT-oriented applications such as telecommunications, nanobots, quantum computers or fields like metallurgy.
It's like Arsenic. The FDA should regulate it in foods and drugs, but they don't have much to say about the GaAs semiconductor industry.
The problem is more that the cosmetic industry has embraced the nanotechnology buzzword to make their new products seem super-high-tech and this makes the FDA a natural candidate for initial regulations, but they certainly won't be the only agency regulating them!
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.
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Here's a study conducted by researchers from NASA, Wyle Labs, UofT Medical:
http://toxsci.oxfordjournals.org/cgi/content/full
... they approve and allow dangerous chemicals in USA milk :/ rBGHintro.php/
http://www.vpirg.org/campaigns/geneticEngineering
Just get them to start using guns and smoking tobacco.
...
Then the FDA won't be allowed to regulate them.
Of course, I'm not sure what impact gun-toting cigar-smoking nanobots would have, but it would sure help the miniaturized saloon and spitoon industries
-- Tigger warning: This post may contain tiggers! --
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
The excerpt alludes to a painfully obvious fact that the article authors are trying to gloss over: The ingredients being complained about have been in use far longer than the concept of nanotechnology has even existed.
They are using "nanotech" as a fud smokescreen to get stricter controls over a whole bunch of ingredients. Like zinc oxide (the sunscreen ingredient refered to in the quote). The definition of nanoingredients presented in the article is deceptively vague:
That includes basically every molecule in existence other than very large things like soot, DNA strands, long nanotubes (ironically) etc.
A better definition for regulatory purposes should define "nanoparticles" (admittedly a terrible term, but we're stuck with it now) as being particles between two appropriate threshold sizes - a minimum and a maximum, and whose interactions are not completely determined by chemical properties. (i.e. there is some "engineered" attribute which is not obvious given the composition.)
argumentum ad fallacium: Fallacy of defining a fallacy which allows one to dismiss the argument in question.
Even so, there is well-established legal precedent that the Commerce Clause together with the elastic ("...necessary and proper...") clause allows Congress to regulate activity which might effect the market for interstate commerce even where the activity itself is neither "interstate" nor "commerce", including growing agricultural products (the seminal case concerned wheat, the recent reaffirmation concerned marijuana) for personal consumption.
I am not going to differentiate between nano-tech and nano-particles here even though I understand there is a difference between the two, but in the case of this post, I don't think the two terms need to be differentiated. To do so would be hair-splitting.
I can see how the FDA could regulate nano-tech if it is an ingredient in food, medicine, cosmetics or if it is a "medical device". I can not see how they would be involved if it was a more "industrial" component (say an ingredient in paint or a component in some high tech alloy).
It is the use more than the component that really makes a difference here. I really doubt that nano-tech used in electronics will ever be considered able to be regulated by the FDA until it is incorporated into something like a pacemaker.
I hope I am correct in this but with our current state of government in the U.S.A. it is really hard to tell. It is probably only a matter of time until the FDA comes under the umbrella of "Homeland Security" then who knows what will happen.
You sound pretty biased yourself! If that info is so available, reference some of it, but be sure it's an objective source, and not as biased in your direction as you say FDA is.
Sorry, but you hit a nerve. FDA is, as I mentioned in an above post, deliberately injected between the public and the industries it regulates. As with any government entity, its political biase is reflected by the current Administration. The Commissioner, after all, is appointed by the Pres and serves at his pleasure. And the Commissioner also runs the FDA in a pretty direct manner. He definately influences the way FDA does its job.
if you don't like it, vote for the other party next time.
Personally, I don't always like the things FDA does. I don't like the way they've sat on the morning after pill - and neither did the director of the Office of Women's Health at the FDA. She resigned - after a productive career in the government - specifically to fight that one issue!
Like I also said above - I've worked for FDA for almost thirty years, and find my fellow employees to be largely a dedicated hard working bunch. We work hard every day to ensure that your food, drugs, et. al., are safe, effective, and unadulterated. it isn't an easy job. Our budget, like the rest of the Feds, gets smaller every year, and the workload gets bigger. As our workforce gets older, its gonna get smaller, but the amount of work we do won't!
If you want that to change, lobby your congressman/woman, but if you succeed, expect your taxes to go up. Safety and effectiveness ain't cheap! You can also expect industry to continue to gripe about us - as they constantly do.
if you think we are industry flunkies - then why are FDA inspectors often required to be accompanied by US Marshalls when we seize products? We have been shot at, attacked and run out of establishments we have gone to to inspect. That doesn't sound like industry likes us much better, does it?
Like I said, we are deliberately placed between industry and the public - and its rarely possible to please both at once - and sometimes neither one!
"Money is truthful. If a man speaks of his honor, make him pay cash." Notebooks of Lazarus Long, Robert A. Heinlein
It's funny, but when the nanoparticles are produced by internal combustion engines - the source of the most potent non-radioactive carcinogens known - or from plasticisers used in plastic goods etc., the US government is positively glacial in its response.
:v)
Start developing a new technology that promises to completely revolutionise the manufacturing and supply industries as we know them, and POW! Suddenly there is activity to ban it because it might produce nasty chemicals if done in an inconsiderate manner.
So much for US industry.
At this rate the US will be buying its nanotechnology from Venezuela.
Vik
What I find amusing about sodium (or potassium) cyanide is that it is such a well known toxin (and so heavily used in industry, as you point out) that it's relative toxicity is often overstated. The LD50 of sodium cyanide for oral administration (in rats, anyway) is 6.4 mg/kg. In comparison, that of caffeine is just 30 times greater, at 192 mg/kg. If we take into account that a single molecule of caffeine weighs 4 times that of sodium cyanide, the molar toxicity of caffeine is only 7.5 times less than that of sodium cyanide. When we then compare that to a supertoxin like batrachotoxin (from the skin of some tropical frog), with an LD50 of just 1 or 2 micrograms/kg (and a molecular weight 12 times that of cyanide), sodium cyanide looks downright tame. Then again, maybe the surprise in the above comparison is just how toxic caffeine is... or that oral doses in rats aren't always indicative of the potential of a toxin by other routes. Inhaled hydrogen cyanide is much more nasty and easily produced anywhere large amounts of sodium cyanide are stored...
Shouldn't you be doing something useful?
FTA:
The legal filing was synchronized with the release of a report by the environmental group Friends of the Earth that highlighted the growing number of personal care products with nanoingredients, defined as smaller than 100-millionths of a millimeter.
From Steven Den Beste:
Lemme see: 1/100 million == 10^-8. A millimeter is 10^-3 meter. Multiply them together and you get 10^-11 meter. So they're talking about banning particles smaller than 10 picometers.
The smallest atom is helium, which is 280 picometers in diameter. The only things smaller are elemental particles such as protons, neutrons, and electrons. I guess we have to ban everything made out of them, right?
It would be interesting to know if this is the Wapo's mistake, or if Friends of the Earth really are that clueless. I wouldn't want to bet either way.
All via Instapundit.