The United States Food and Drug Administration (FDA) regulates genetically engineered (GE) animals under the Federal Food, Drugs, and Cosmetics Act (FFDCA) and National Environmental Policy Act (NEPA) regulations. FDA is now issuing guidance on how it intends to apply these regulations, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs". The guidance itself is not legally binding but will describe the agency's interpretation of law. It will not apply to laboratory animals for research purposes, only food and pharmaceutical GE animals. Critics of FDA regulation argue that current regulation is inadequate, and warn of possible environmental, ecological and physiological hazards of bioengineered animals. The 25-page document is available at, and is open to public comment until 18 November at under reference Docket FDA-2008-D-0394.


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