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FDA Asked to Regulate Nanotechnology
Posted by
ScuttleMonkey
on Wed May 17, 2006 05:31 PM
from the fda-begins-regulating-ipods dept.
from the fda-begins-regulating-ipods dept.
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."
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cynical writes "WorldChanging has a lengthy interview with Chris Phoenix and Mike Treder of the Center for Responsible Nanotechnology, a non-profit group helping to make sure molecular manufacturing is developed as safely as possible. In the article they talk about their policy task force (which includes folks like Ray Kurzweil, David Brin, and Jaron Lanier), the risks and benefits of nanofactories, and why open source is so important to the responsible development of nanotechnology."
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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)
Parent
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.
Parent
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.
Parent
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
Parent
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
Parent
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
Parent
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.
Parent
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:3, Informative)
see concern story here [npr.org] and a rebuttal here [softmachines.org] for examples
Re:Oh Gawds... (Score:5, Insightful)
This is NOT a request for blanket regulation, as some of the more knee-jerk replies suggest.
-dB
Parent
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.
Parent
An excellent way to get nothing done! (Score:4, Insightful)
and they say "Shure!" (Score:4, Insightful)
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.
Parent
Remember Kids (Score:5, Funny)
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.
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
The last thing Nanotechnology needs... (Score:5, Funny)
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.)
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
Re:Luddites... (Score:3, Insightful)