FDA Asked to Regulate Nanotechnology 248
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."
From the Article (Score:4, Funny)
Oh Gawds... (Score:5, Insightful)
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.
Re:Oh Gawds... (Score:5, Insightful)
Re:Oh Gawds... (Score:5, Insightful)
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.
Re:Oh Gawds... (Score:5, Insightful)
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.
Re:Oh Gawds... (Score:2)
Both of which (tampons and contact lenses) can mess you up if done irresponsibly.
It's a good thing to get some basic protections against ignorant use of this before we end up with another form of pollution (BT corn? Resistant bacteria? Resistant wind-pollinated weeds?)
A recent test showed that one type of nano particle killed fish when some was put in the wa
Re:Oh Gawds... (Score:2)
Re:Oh Gawds... (Score:2)
Re:Oh Gawds... (Score:2)
WHAT??!!! Cough splutter cough ...
Re:Oh Gawds... (Score:3, Insightful)
Not really. What gives nanotech its potential is not its scale persay, but the fact that at that scale, quantum effects come into play. This gives nanoscale materials very different properties than they would have at the large scale. Nanotech materials, as a generalization, tend to be very reactive (even gold nanoparticles)
Re:Oh Gawds... (Score:4, Insightful)
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
Re:Oh Gawds... (Score:3, Funny)
Problem solved!
Re:Oh Gawds... (Score:5, Funny)
The only thing I like about that idea is the resulting acronym...
(D)epartment (O)f (N)ano(T)echnology
Re:Oh Gawds... (Score:2)
As far a regulating nanomaterials used in consumer products, the FDA is a perfectly sensible agency for this. If some window cleaner contains nanamaterials that might cause silicosis if inhaled, for example, oversight of the clinical trials to determine that product's safety are the FDAs normal business.
It's no more odd than the FDA regulating la
Re:Oh Gawds... (Score:3, Insightful)
In any case, TFA is talking about the FDA regulating nanomaterials in products already regulated by the FDA, which seems right. In general, raw materials which are not biologically active may become so if used as nanomaterials, and *someone* should enforce testing requirements on nanomaterials before they're allowed into consumer products. Preferably an agency which already oversees clinic
Look into the Constitution (Score:4, Insightful)
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
Re:Look into the Constitution (Score:2)
What does the part about nanotechnology say?
Re:Look into the Constitution (Score:2)
Re:Look into the Constitution or the Swimsuit idea (Score:3, Informative)
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", in
Re:Oh Gawds... (Score:2)
I was hoping the "Department of Federal Whacky Unrealistic Luddite Fears of Science Fiction Movies" would get involved.
Seriously, nanotechnology doesn't need to be regulated because it really isn't a technology per say (other than marketing hype of technology that uses measurements in nano meters) and poses as much of a threat to civilization as say... Pollen.
I'm sure if you ate Nano Carbon tubes it won't be healthy for you, but so is eating le
Re:Oh Gawds... (Score:5, Interesting)
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.
Seems to me EPA (Score:2)
Re:Sick of the terminology (Score:2)
Better yet, replace 'nanoparticles' with 'bullets' and watch the NRA go ape-shit.
From the 1st page of www.fda.gov (Score:3, Informative)
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
Re:Oh Gawds... (Score:2)
Re:Oh Gawds... (Score:3, Informative)
see concern story here [npr.org] and a rebuttal here [softmachines.org] for examples
Re:Oh Gawds... or is Makeup Nanotechnology? (Score:2)
Re:Oh Gawds... (Score:5, Insightful)
This is NOT a request for blanket regulation, as some of the more knee-jerk replies suggest.
-dB
Re:Oh Gawds... (Score:4, Insightful)
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 [wikipedia.org] approach [wikipedia.org] carries [wikipedia.org] no [wikipedia.org] risks [wikipedia.org].
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.
Re:Oh Gawds... (Score:2)
Re:Oh Gawds... (Score:2)
Fair enough on all points.
The risk is in numbers (Score:2)
No, it's not possible at all. Imagine a highly toxic substance, for instance Sodium Cyanide. NaCN is so toxic that, literally, a sniff can kill you. Yet it's widely used worldwide, one of the most used chemical compounds in metal plating. But very few people die from cyanide poisoning, exactly because it's so toxic that everyone know
Re:The risk is in numbers (Score:2, Interesting)
What I find amusing about sodium (or
Re:The risk is in numbers (Score:2)
I agree with your basic point that you can't easily detect the sort of toxicity that leads to death/illness with low frequency, O(1 in 1M) or so. And the really bad stuff is self-evident, as you note. But there's the class of substances that occupy the middle ground- not obviously fatal, but pretty frickin' bad. It sure would be nice to catch these in the lab.
Lead is an interesting example.
The aqueduct that supplied water to the French city of Nimes had parts made of lead. It was operated continuously fo
Re:The risk is in numbers (Score:2)
Especially since NaCN is a nonvolatile solid that boils at 1500 degrees. A sniff of anything at that temperature will kill you. Hit it with a little acid, then you've got HCN, which is gaseous. What I've always wondered is how they determine the detectable odor threshold for toxic gases (1-5 ppm for HCN) without killing people.
Industrial facilities that use cyanides on large scale take every imaginable precaution, including "dead man" drills, in whi
Re:Oh Gawds... (Score:3, Insightful)
It's more guided towards "tiny independent things."
So the nanometer features of your microchips aren't strictly nanotechnology, because they aren't going anywhere without the other 50 million that are there.
Re:Oh Gawds... (Score:2)
Nanotechnology will never mean "nano-scale robots" the was some SciFi fans want it to, as we already have words for actors and tools at that scale: cells and enzymes.
Re:Oh Gawds... (Score:2)
Drugs? (Score:2)
Re:Drugs? (Score:2)
dunno about tobacco though.
Re:Oh Gawds... (Score:2, Insightful)
Re:Oh Gawds... (Score:2)
So maybe it should be limited to nanotech applied in the food and drug area. They got no biz in anything else.
Re:Oh Gawds... (Score:2)
Re:Oh Gawds... (Score:2)
FYI, the fence isn't there to protect your fingers, it's there to help you cut strai
An excellent way to get nothing done! (Score:4, Insightful)
Re:An excellent way to get nothing done! (Score:2)
Yeah, just the same way that FDA regulation of prescription drugs means no one does pharmaceutical research in the US.
Re:An excellent way to get nothing done! (Score:2, Insightful)
Buy a hunting hearing enhancing amplifier [midsouthsh...supply.com] at the sporting goods store: $300 at most. Buy a regulated hearing aid from an audiologist: $5000.
Re:An excellent way to get nothing done! (Score:2)
Re:An excellent way to get nothing done! (Score:2)
Re:An excellent way to get nothing done! (Score:2)
As an emerging technology of which the potentially harmful effects are still unkown even to those creating products based on nantech, what do you suggest be done to protect the people? Or are you really trying to argue that nanotechnology is proven to have no ill effects? Just recently in the UK, a manufacturer was forced to recall their product that contained nanotechnolo
and they say "Shure!" (Score:4, Insightful)
Re:and they say "Shure!" (Score:2)
As I understand it, the FDA regulates products sold, not research (aside from clinical trials). You can research any amazing product you want, and foreign companies can manufacture any amazing product they want. But both will run into the FDA at the point where you sell the product in the U.S. No sooner, and no later, same barrier for both. (And only if the FDA applies to that particular product category.)
In a word, that's a bogus argument. -- Paul
Re:and they say "Shure!" (Score:3, Informative)
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...
Re:and they say "Shure!" or what's next (Score:4, Insightful)
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.
Want an opinion from a bioethicist? (Score:2)
Re:and they say "Shure!" (Score:2)
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...
And people who are not at all concerned about self-replicating robots going amock have never had to debug a production system.
( of course, the likelyhood that the self-replication will work perfectly, while the "protect^H^H^Hdestroy all life" code malfunctions, is pushing it. I expect the bugs to go out of control, and promptly die from poorly design
Remember Kids (Score:5, Funny)
Gray Goop On? (Score:2)
Given that nantechnology has been used in the formulation of sun screens, one could then reasonably ask:
(For the humor impaired, this is a parody of the "Pardon me, do you have any Gray Poupon?" mustard commercials.)
Progress! (Score:5, Insightful)
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.
Re:Progress! (Score:2)
Re:Progress! (Score:2, Funny)
All we need to do is regulate thought. yeah, that's it. regulate thought....
Re:Progress! (Score:2)
Re:Progress! (Score:2)
LS
Scientists will merely switch to another scale (Score:2, Insightful)
I can imagine the FDA breaking out their electron microscopes, deciding if a molecule falls within their scope of focus.
Re:Scientists will merely switch to another scale (Score:2)
How to kill nanotech in its infancy... (Score:5, Interesting)
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.
Re:How to kill nanotech in its infancy... (Score:3, Interesting)
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
Re:How to kill nanotech in its infancy... (Score:2)
> industry and the aviation industry are regulated.
What makes you think that this isn't exactly what the environmental groups pushing for regulation
want? Sadly, many in the movement are little more than a bunch of anti-technology luddites..
Re:How to kill nanotech in its infancy... (Score:2)
First off, the medical [bbc.co.uk] and aviation [chicagobusiness.com] industries are doing quite well, thank you. So process-level regulation is not the impending doom you make it out to be. Moreover, the example you give of piston-driven aircraft still using mechanical injection is ridiculous. My bicycle is still pedal powered... surely you don't believe that federal process-regulation of bicycle construction is the cause. Mechanical injection is reliable, cheap to build,
Riiight... (Score:2)
The reasons these industries are highly regulated is because of the risks involved, which should be fucking obvious. Even with draconic regulation, there are still high levels of deaths related to faulty equipment, malpractice, and pharmaceuticals that weren't teste
Kerrrazzzy business idea.... (Score:2)
2) Charge them for a full MRI, but just put them through a big polo-mint shaped hole that goes "bang-bang-bang"
3) Show them a pre-shot MRI from a fat person. Talk up the arterial plaque
4) Motivated by imminent death, patient loses weight. Patient is happy.
5) Profit!
Great idea (Score:2)
Makes perfect sense. Who better than the FDA to regulate skis [atomicski.com]?
Of course, there are other things that "can penetrate cells and tissues, migrate through the body and brain and cause biochemical damage." Many of them occur in nature. Some of those (like buckyballs in smoke) are even nanoparticles.
Re: (Score:2)
This is pure insanity (Score:2, Interesting)
By placing a label on these products, consumers will irrationally be prejudiced against them. You should no
Re:This is pure insanity (Score:2)
"Life: noun - the whim of several billon cells to be you for a while"
Re:This is pure insanity (Score:2)
The last thing Nanotechnology needs... (Score:5, Funny)
Re:The last thing Nanotechnology needs... (Score:2, Funny)
*sounds of crickets*
Ah, well, I'll be here all week anyway...
Sure thing! (Score:2)
Nanotech is more than tiny machines (Score:5, Insightful)
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.)
Re:Nanotech is more than tiny machines (Score:2)
Or on our flippers.
FDA Regulation? (Score:2)
well, at least the ones that weren't already saying 10+ years that is.
I'm gleefully over-joyed at this news, since we all know the Government will keep us all safe because it knows best.
*feh*
Nanotechnology versus cute nanoparticles (Score:3, Insightful)
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!
A Study (Score:5, Informative)
Here's a study conducted by researchers from NASA, Wyle Labs, UofT Medical:
http://toxsci.oxfordjournals.org/cgi/content/full
No faith in the FDA when ... (Score:2, Informative)
http://www.vpirg.org/campaigns/geneticEngineering
Re:No faith in the FDA when ... (Score:2)
Alex Krycek (Score:2, Troll)
Indeed (Score:2)
Easy solution to stop regulation of nanobots (Score:2, Funny)
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
Not as dumb as it sounds. (Score:2)
Ingredients in question aren't even all "nanotech" (Score:3, Interesting)
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.)
puzzled (Score:3, Insightful)
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.
Regulate existing ones first (Score:3, Insightful)
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
article has giant error (Score:3, Interesting)
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.
The Scare stories have already started... (Score:2)
http://www.economist.com/science/displayStory.cfm? story_id=6795430 [economist.com]
Re:Luddites... (Score:2)
Sunscreen (one of the areas of nanotech application in TFA), for instance, is a nonprescription drug currently regulated by the FDA, used to prevent various kinds of disease.
Re:Luddites... (Score:3, Insightful)
Re:Are they kidding? (Score:3, Insightful)
The FDA regulates (see their homepage [fda.gov]) 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 somet
Re:you think nanoparticles are bad? (Score:2)
Re:Oh Good - Just What a Fledgling Industry Needs. (Score:2, Interesting)
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 C