Hi All,
Food producers will not be required to label meat, poultry or seafood as being sourced from genetically modified animals, according to a final guidance for industry on the regulation of Genetically Engineered, (GE), animals under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act. Details, released today, can be found here:
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01944.html
and here:
http://www.fda.gov/cvm/GEanimals.htm
Tex
Regulations Released On Genetially Modified Animals
Moderators: Rosie, Jean, CAMary, moremuscle, JFR, Dee, xet, Peggy, Matthew, Gabes-Apg, grannyh, Gloria, Mars, starfire, Polly, Joefnh
Regulations Released On Genetially Modified Animals
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
I'm not sure what this means:
Gloria
Does that mean they consider changes to the DNA to be a drug? I guess I don't really understand how they change an animal's DNA.The FFDCA defines “articles (other than food) intended to affect the structure or any function of the body of man or other animals" as drugs. An rDNA construct that is in a GE animal and is intended to affect the animal's structure or function meets the definition of an animal drug, whether the animal is intended for food, or used to produce another substance. Developers of these animals must demonstrate that the construct and any new products expressed from the inserted construct are safe for the health of the GE animal and, if they are food animals, for food consumption.
Gloria
You never know what you can do until you have to do it.
Hi Gloria,
That's the way I read it. They probably justify this definition based on the way that most gene splicing is done, namely by means of restriction enzymes. However, that's not the only way that gene splicing can be done. It can also be done by means of viral vectors, liposomes, or DNA guns. I totally disagree with their definition, since gene splicing is not a "normal" drug function. For one thing, using viruses or DNA guns, can by no stretch of the imagination be considered a normal drug function. I guess the government can call it anything they want, though, since they do that with some degree of regularlarity, thus proving the accuracy of one of George Orwell's predictions in his novel, 1984. (Newspeak?)
Here's a primer on the basics of gene splicing:
http://library.thinkquest.org/19037/therapy2.html
Tex
That's the way I read it. They probably justify this definition based on the way that most gene splicing is done, namely by means of restriction enzymes. However, that's not the only way that gene splicing can be done. It can also be done by means of viral vectors, liposomes, or DNA guns. I totally disagree with their definition, since gene splicing is not a "normal" drug function. For one thing, using viruses or DNA guns, can by no stretch of the imagination be considered a normal drug function. I guess the government can call it anything they want, though, since they do that with some degree of regularlarity, thus proving the accuracy of one of George Orwell's predictions in his novel, 1984. (Newspeak?)
Here's a primer on the basics of gene splicing:
http://library.thinkquest.org/19037/therapy2.html
Tex
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.