FDA is overreaching and is seeking to classify anything genetically altered as a "drug". For instance if a breeder uses crispr to fix genetic defects in a breed, they will have to go through FDA and the animals created will be considered drugs.
http://gizmodo.com/the-fdas-newly-proposed-gmo-rules-are-nonsense-1791519749
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM113903.pdf
Comment to the FDA
https://www.regulations.gov/document?D=FDA-2008-D-0394-0279
the altered genomic DNA in an animal is a drug within the meaning of section 201(g) of the FD&C Act because such altered DNA is an article intended to affect the structure or function of the body of the animal, and, in some cases, intended for use in the diagnosis, cure, mitigation, treat ment, or prevention of disease in the animal
>>8650508
Damn. That sucks balls. I hate stupid people who don't know what they are talking about and are terrified of GMOs.
What about crops? Aren't almost all crops genetically modified to some extent? Or does have to be modified in a certain way? I am especially thinking of corn.
>>8650513
93% of crops grown are GMO.
but OP, I fully support GMOs being heavily regulated if not banned, I'm going to submit my comment in support.
>>8650508
the FDA is cool though so i dont see a problem
there is already too much unregulated shit out there
>>8650508
Calling it a "drug" is kinda dumb, but I can understand the reasoning for trying to place them under the authority of the FDA.
>>8650702
>>8650884
No, it's nuts.
Most of the time we work with alleles which have been tested by humans for thousands of years, of which we have a pretty impressive mechanistic understanding.
Not to mention that genome editing is done with high-precision.
Because of this only huge corporations can support the time and money investment to pass unnecessarily strict regulations.
>>8650899
I don't see anything in the draft that looks like "unnecessarily strict regulations". If I'm reading it right, they want to place "develop a drug to cause an animal to do X" and "engineer an animal that does X by itself" into the same regulatory category.
>>8650508
Meh. Maybe the heightened regulations will finally make leftist scaremongers shut up.
Also, this seem only to apply to animals, and most GMO foods are plants anyway
Don't really see the problem. Doesn't seem to impact academia or biotech industry, but I just skimmed it in 20 seconds so tell me if I'm wrong.
>>8650508
Good. If you genetically modify an organism you have literally changed its DNA. It is not the same as the unaltered version.
I honestly don't get people who say they're the same
Reminder: People like anon here >>8651186 vote
>>8651186
Good, when your dog has puppies and they have a novel mutation the FDA can come in and declare them illegal drugs. That sounds great.
This regulation is absolutely insane.
>>8650508
Monsanto controls the FDA. I suppose this is a way to help monopolize GMO products for Monsanto.
>>8651958
I know this is meant as sarcasm, but Monsanto is actually becoming more and more of a data company rather than a GMO/chemical supplier.
oh boy...
There is a long history of traditional breeding efforts producing plants with unsafe levels of toxins, even to the point of causing contact dermatitis in harvesters or grocery workers. And yet, no safety testing is required before any new plants are brought to market.
If I said that I made a plant using genetic engineering and it had a small chance of causing rashes in part of the population, the anti-GMO I nternet would flip a shit and probably try to shut my business down.
But if I bred a new variety of peanut, a plant that is notorious for triggering potentially deadly allergic reactions in a non-trivial subset of the population, and tried to sell it, no one would bat an eye.
What I want is a common sense level of testing across the board.
>>8652195
That long history is that it very rarely happens. With gmo you could do it consinstently with all seeds in a week intentionally. You could also take those allergenes from peanuts and put them in a carrot where classic shit is limited by what's already there. Trying to equalize the risk factor is pure insanity when gmo opens up way more ways to fuck things up at higher percentage.
>>8652213
Only if you're bending the definition of GMO.
>>8650586
This is dumb. GMO's have proven to be safe.
>>8652456
Until now the alimentation GMOs we make all proved to be safe but in the close future we may want to create functionalized organisms, possibly producing new chemicals or having completely novel features. Somehow the fact that it has to undergo FDA agreement could make SynBio more acceptable.
>>8652195
>Toxins
what the fuck is it about genetics that causes moralfaggots such massive asshurt?
>>8650508
so?
I really hope the first true marvel of genetic engineering is an actual cat-girl gf made in the basement of some degenerate scientist rather than what the public would expect it to be (like some gay, carbon-fixing super plant made by Monsanto).
P.S. you guys will be the first to know if my project is a success