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Genetically Engineered Animals

Picture of goats, a chicken, a cow, and pigs


Genetic engineering is a targeted and powerful method of introducing desirable traits into animals using recombinant DNA (rDNA) technology.  DNA is the chemical inside the nucleus of a cell that carries the genetic instructions for making living organisms.

In January, 2009, the Food and Drug Administration issued a final guidance for industry on the regulation of genetically engineered (GE) animals.  The guidance explains the process by which FDA is regulating GE animals and provides a set of recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law.  While the guidance is intended for industry, FDA believes it may also help the public gain a better understanding of this important and developing area.

What is FDA Doing?

Final Documents Released January 15, 2009:

Draft Guidance Documents Released September 18, 2008:

  • Draft Guidance for Industry #187 - Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs | html | pdf |

  • Transcript for Media Briefing on FDA’s Draft Guidance for Industry on the Regulation of Genetically Engineered Animals

    September 18, 2008 [pdf 79KB] Audio [276 KB MP3]

Information for Industry

Consumer Health Information

Related Information

Web Page Updated by hd - January 16, 2009, 9:45 AM ET

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