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Thread: FDA Issues Final Guidance on Regulation of Genetically Engineered Animals

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    Administrator Islander's Avatar
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    Default FDA Issues Final Guidance on Regulation of Genetically Engineered Animals

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    The Food and Drug Administration (FDA) has issued final guidance on its approach to regulating genetically engineered (GE) animals.
    The guidance is aimed at industry; however, FDA believes it may also help the public gain a better understanding of this important and developing area. The guidance explains the process by which FDA is regulating GE animals.
    FDA invited public comments for 60 days after the release of its draft guidance on regulating GE animals in September 2008. The agency received comments from groups and individuals ranging from consumers and animal advocates, to food producers and trade associations, to academics and researchers. FDA considered the approximately 28,000 public comments in producing the final guidance.
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    Genetic Engineering

    Genetic engineering is a process in which scientists use recombinant DNA (rDNA) technology to introduce desirable traits into an organism. DNA is the chemical inside the nucleus of a cell that carries the genetic instructions for making living organisms. Scientists use rDNA techniques to manipulate DNA molecules.
    Genetic engineering involves producing and introducing a piece of DNA (the rDNA construct) into an organism so new or changed traits can be given to that organism. The rDNA construct can either come from another existing organism, or be synthesized in a laboratory. Although conventional breeding methods have been used for a long time to select for desirable traits in animals, genetic engineering is a much more targeted and powerful method of actually introducing specific desirable traits into animals.
    Genetic engineering is not a new technology. It has been widely used in agriculture, for example, to make crops like corn and soy resistant to pests or tolerant to herbicides. In medicine, genetic engineering is used to develop microbes that can produce pharmaceuticals. And in food, genetic engineering is used to produce enzymes that aid in baking, brewing, and cheese making.
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    Benefits of GE Animals

    GE animals hold great promise for human and animal health, the environment, and agriculture.
    • Health protection of animals – Animals are under development to be more resistant to very painful and harmful diseases, such as infection of the udder (mastitis) in dairy cows and "mad cow" disease (bovine spongiform encephalopathy) in all cattle.
    • New source of medicines – Animals can be engineered to produce particular substances, such as human antibodies, to make infection-fighting drugs for people. These "biopharm" animals can change the way we treat chronic diseases, such as bleeding disorders, by providing large quantities of safe, health-restoring proteins that previously were available only from human cadavers.
    • Transplantation – Pigs are being engineered so that their cells, tissues, or organs could be transplanted into humans with a reduced risk of immune rejection.
    • Less environmental impact – Food animals are being engineered to grow more quickly, require less feed, or leave behind less environmentally damaging waste.
    • Healthier food – Food animals, such as pigs, are under development to contain increased levels of omega-3 fatty acids, providing a more healthful product. Livestock can also be engineered to provide leaner meat or more milk.
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    GE Animals Regulated Under New Animal Drug Provisions

    FDA regulates GE animals under the "new animal drug" provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), and the agency must approve them before they are allowed on the market. The FFDCA defines a drug as "an article (other than food) intended to affect the structure or any function of the body of man or other animals." Therefore, the rDNA construct is a drug because it is intended to change the structure or function of the body of the GE animal.
    FDA will review food and animal feed from GE animals before the food or feed can be marketed. "We want the public to understand that food from GE animals will not enter the food supply unless FDA has determined that it is safe," says Bernadette Dunham, D.V.M., Ph.D., the director of FDA's Center for Veterinary Medicine.
    FDA may exercise "enforcement discretion" over some GE animals, based on their potential risk and on a case-by-case basis. This means that the agency may not require premarket approval for a low-risk animal. For example, the agency is not requiring premarket approval for GE lab animals used for research, and did not require approval of a GE aquarium fish that glows in the dark. FDA does not expect to exercise enforcement discretion for animal species traditionally consumed as food.
    The guidance will help industry comply with FDA's requirements and will help the public understand FDA's oversight of GE animals and food from such animals.

    This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
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    For More Information

    Genetically Engineered Animals
    www.fda.gov/consumer/updates/ge_animals_diagram091808.html
    FDA's Final Guidance on the Regulation of Genetically Engineered Animals
    www.fda.gov/cvm/Guidance/fguide187.pdf
    Other publications on genetically engineered animals www.fda.gov/cvm/GEAnimals.htm
    Date Posted: January 15, 2009


    Source: http://www.fda.gov/consumer/updates/...als011509.html

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    Veteran Member mellowsong's Avatar
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    Default Re: FDA Issues Final Guidance on Regulation of Genetically Engineered Animals

    Excuse me, but the only "guidance" I see here is blanket permission for scientists to do anything they want. Not a word that they will have to be labeled so the consumer continues to have littlefree choice in what they eat, especially if on limited income. GMO crops are mentioned (of course) like they are wonderful, with no mention of the damage to the environment, death of animals eating GMO corn and now messed up honeybees. More brainwashing. I'm sure the VAST majority of comments were from people like myself opposing GMO and insisting on appropriate labelling. The FDA is totally corrupt and needs to be disbanded.

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    Default Re: FDA Issues Final Guidance on Regulation of Genetically Engineered Animals

    Mellowsong, this is basically just a press release. To read the actual Guidance you will have to click the second ink at the bottom of the article. It will dl the Guidance which is a pdf.

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    Default Re: FDA Issues Final Guidance on Regulation of Genetically Engineered Animals

    The "desirable traits" mentioned in this release are a matter of subjective interpretation. There is no need to breed a cow resistant to mastitis if she and her environment are kept clean. Nor is there need to modify a cow's genes for increased milk production; these animals are so overbred for production using conventional means that they are exhausted and their life span shortened. Again with pigs: raise them on pasture rather than in CAFOs and you will have some of the healthiest meat and fat imaginable.

    The science of genetic engineering is going at the problem of inadequate nutrition backward. Replenish the depleted soil with organic (not chemical) nutrients, and the plants grown on it, and the animals fed on those plants, will nourish us once again.

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    Veteran Member mellowsong's Avatar
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    Default Re: FDA Issues Final Guidance on Regulation of Genetically Engineered Animals

    Thanks Islander. After reading most of it, I still see nothing that protects the consumer, especially if they allow them in the food supply(which is already happening):

    We note that labeling of food from GE animals would be subject to the same requirements as food from non-GE animals, and that as with food from GE plants3, the fact that the animal from which food was obtained was genetically engineered would not be material information with respect to labeling. However, if food from a GE animal is different from that of its non-engineered counterpart, for example if it has a different nutritional profile, in general that difference would be material information that would have to be revealed in labeling.



    The FDA has stated multiple times that GMO crops are NOT materially different from non GMO and I'm sure the same blanket "assurance" will be applied to GMO animals.


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