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FDA Announcement

January 16, 2009

FDA announced today the availability of a “guidance document”.  The purpose of this guidance document is to assist producers of “genetically engineered” (GE) animals obtain “protection” for the “heritable traits” of the GE animal.  In other words, FDA is encouraging the development of GE animals that possess heritage traits, including animals intended for food consumption.  The new guidance document will allow FDA to “guide” developers of GE animals through the process of how to receive approval for their GE animals.

The “guidance document” announced today is truly amazing for what it reveals about our federal government.  In short, we now seem to be entering the world of the macabre and bizarre.  In today’s notice, FDA states that its Center for Veterinary Medicine (CVM) (by the way, the same CVM that is implementing NAIS) will be responsible for assisting producers of GE animals who wish to obtain protection and approval of the GE animals’ “heritage” traits, and that creators of GE animals “should come to CVM early in the process.”  In today’s notice, FDA states that the following types of animals can now seek approval for distribution in the food chain, animals which can:

(1) enhance food quality or agronomic traits (e.g., pigs with less environmentally deleterious wastes, faster growing fish); (2) improve animal health (e.g., disease resistance); (3) produce products intended for human therapeutic use (e.g., pharmaceutical products or tissues for transplantation; these GE animals are sometimes referred to as “biopharm” animals); (4) enrich or enhance the animals’ interactions with humans (e.g., hypo-allergenic pets); (5) develop animal models for human diseases (e.g., pigs as models for cardiovascular diseases); and (6) produce industrial or consumer products (e.g., fibers for multiple uses).

Whatever happened to the world in which animals simply reproduced according to the laws of nature?

 

 

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