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U.S. Department of Health and Human Services

Animal & Veterinary

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Fact Sheet

Genetically Engineered Animals

Updated January 16, 2009

Genetically engineered (GE) animals were first developed in the 1980s.

Genetic engineering generally refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. When scientists splice together pieces of DNA and introduce a spliced DNA segment into an organism to give the organism new properties, it’s called rDNA technology. The spliced piece of DNA is called the rDNA construct. A GE animal is one that contains an rDNA construct intended to give the animal a new trait or characteristic.

Genetic engineering already is widely used in agriculture to make crops like corn and soy resistant to pests or herbicides. In medicine, genetic engineering is used to develop microbes that can produce pharmaceuticals. In food processing, genetic engineering is used to produce microorganisms that more efficiently aid in baking, brewing, and cheese-making.

FDA pre-market approval requirements apply to GE animals. The FDA is issuing its Guidance on the Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs after having considered all comments received on the draft guidance. As a result of our consideration of the comments, some areas of the guidance, particularly those relating to transparency, have been clarified or amplified.

The aim of the guidance is to help industry and the public gain a better understanding of the regulatory process in this important and developing area.

Most GE animals are still quite early in development. Scientists are developing GE animals for a variety of applications, such as to:

  • Produce pharmaceuticals to be used for other animals and humans
  • Decrease the environmental impact of large-scale agricultural practices by decreasing the amount of chemicals such as phosphate in manure, thereby reducing water pollution
  • Serve as a source of cells, tissue, and organs closely matched to humans so that they may be able to be transplanted into humans without rejection.
  • Produce high value materials such as those used for surgical sutures and personal protection devices such as body armor for military and law enforcement use.
  • Produce highly specific antimicrobials that target disease-causing bacteria such E. coli 0157:H7 or Salmonella.
  • Provide more healthful or more efficiently-produced food.

GE animals that produce pharmaceuticals provide natural production systems for therapeutic proteins previously available only through purification from human cadavers or animal carcasses. Those opportunities include production of growth factors and inhibitors used to treat metabolic diseases, and cancer. The biological similarity to humans could make GE animals an excellent choice for producing therapeutic proteins, and could boost the manufacturing capacity for critically important pharmaceuticals in short supply.

GE animals with new traits for disease resistance, or drought and heat tolerance, may allow for high quality food to be produced in parts of the world where disease, climate, or accessibility of forage material have previously limited the ability to raise food animals.

Genetic engineering may provide fish that can be grown more rapidly and efficiently in aquaculture.

Only food from GE animals that is safe to eat will be permitted into the food supply.

The FDA guidance is a critical step along the regulatory pathway to ensure that GE animals and the products derived from them will be safe. Depending on the animal species and intended use, FDA will coordinate with other federal departments and agencies, such as the U.S. Department of Agriculture and the Environmental Protection Agency, in regulating GE animals.