Animal Biotechnology 

Animal Biotechnology is the spectrum of technologies that range from assisted reproductive technologies to genetic engineering and gene editing, to stem cell technology – currently being used in animals as tools for enhancing food production, for biomedical uses in human and veterinary medicine. The FDA regulates plant and animal biotechnology products in cooperation with the U.S. Department of Agriculture and the U.S. Environmental Protection Agency.[1]

Biotechnology is the controlled application of biology to produce industrial enzymes, improved plants and animals, medicines, pesticides, etc., from living organisms or their parts. Genetic engineering, a special application of biotechnology, is the modification of a plant or animal’s genetic (hereditary) material at the molecular level to produce more desirable qualities. Biotechnology involves the use by industry of recombinant DNA (rDNA), cell fusion, and new bioprocessing techniques.

Plant and animal biotechnology guidance documents are accessible here. Additional related guidance documents and regulatory information is available here.

Updated by Kristin Stiner, November 2020