July 13, 2001
UPDATE ON LIVESTOCK CLONING
FDA's Center for Veterinary Medicine (CVM) has received numerous inquiries about livestock cloning. This CVM UPDATE provides information about CVM's activities in this area.
CVM is considering the safety of animals and their progeny that are produced as a result of somatic cell nuclear transfer (also known as somatic cell clones or NT clones.) "Dolly the Sheep" is the most famous animal produced in this manner, but the technology also has been applied to rodents, cattle, swine, and other species. It involves removing the nucleus of a cell from an adult animal that will be copied and inserting it into an animal egg whose nucleus has been removed. The resulting embryo is implanted into a surrogate mother that carries the fetus to term. In evaluating animal cloning, CVM's first priority is to examine the safety of food products (e.g., meat, milk, eggs) from animals developed through somatic cell cloning but are otherwise unmodified.
CVM has been interested in cloned animals for some time. Last fall, when it became evident that commercial ventures were developing somatic cell clones for use in breeding food-producing animals, CVM contracted with the National Academy of Sciences (NAS) to conduct an independent, scientific peer review of available safety data on cloned animals and the food derived from them. This review, including the safety of cloning to the animals and environment as well as any food derived from the animals, will help CVM decide how these animals should be regulated, including whether there may be circumstances in which CVM ordinarily would not need to exert its authority.
The NAS expert Committee on Defining Science-Based Concerns Associated with the Products of Animal Biotechnology is planning to hold a public meeting this fall to discuss this issue and to elicit safety information from the scientific community. CVM has contacted companies known to be developing cloned animals to inform them that the Center is considering this issue, and to encourage their contributions to this public meeting. Until the Center has scientific information on safety, the Center for Veterinary Medicine has been asking the companies not to introduce these cloned animals, their progeny, or their food products (such as milk or eggs) into the human or animal food supply. CVM has asked the companies to participate in the NAS public meeting, and to be prepared to supply scientific information they have collected on the safety of cloned animals. Any companies involved in livestock cloning that have not yet contacted CVM are encouraged to do so. They may contact Mr. John Matheson at: or by calling 301-827-5895.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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