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Biotechnology: This month, the FDA issued draft guidance on regulating genetically engineered animals (GE) for a 60-day comment period. AGE animal contains a heritable recombinant DNA (rDNA) construct that gives it new traits or characteristics. GE animals include animals that produce pharmaceuticals, industrial or consumer products, as well as animals used as human disease models and for food. Producers must show that the rDNA construct and any products produced by a GE animal are safe. Codex Alimentarius Guidelines will be used to evaluate the safety of food from GE animals. The FDA may also decide not require premarket approval in certain cases, such as when GE animals are lab animals used only for research purposes.

Source: FDA

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Title Annotation:Industry Watch
Publication:Instrument Business Outlook
Article Type:Brief article
Geographic Code:1USA
Date:Sep 30, 2008
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