Genetically Engineered Animals
Updated May 5, 2014
Genetically engineered (GE) animals were first developed in the 1980s.
Genetic engineering generally refers to the use of tools of modern biotechnology and molecular biology to introduce new characteristics or traits into organisms. Scientists can use these tools to introduce new genetic material, or delete or alter existing genetic material to introduce intended, new traits or characteristics.
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 issued 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Engineered Animals Containing Heritable Recombinant DNA Constructs after having considered all comments received on the draft guidance.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.
- Improving dietary nutrient utilization to decrease the potential environmental impact of that nutrient through excretion in manure.
- Serve as a source of cells, tissue, and organs closely matched to humans so that they may be able to be transplanted into humans with a decreased risk of 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 or animal-derived tissues/sources. 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, Centers for Disease Control and Prevention, and the Environmental Protection Agency, in regulating GE animals.