FDA exploring safety aspects of cloned animals

The Food and Drug Administration Center for Veterinary Medicine has received numerous inquiries about livestock cloning, and before it decides whether to regulate this activity—and how—it is gathering information on safety.

In evaluating animal cloning, the agency stated that its first priority is to examine the safety of food products such as meat, milk, and eggs derived from animals that were developed through somatic cell cloning but are otherwise unmodified.

Somatic cell nuclear transfer, also known as somatic cell clones or NT clones, has been applied to sheep, 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 egg in which the nucleus has been removed. The resulting embryo is implanted into a surrogate mother that carries the fetus to term.

Last fall, when it became evident that commercial ventures were developing somatic cell clones for use in breeding food-producing animals, the CVM contracted with the National Academy of Sciences to conduct an independent, scientific peer review of available safety data on cloned animals and the food derived from them.

This NAS review, expected early next year, will include the safety of cloning to the animals and environment as well as food derived from them. One consideration will be whether there may be circumstances in which the agency 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.

The CVM has contacted companies known to be developing cloned animals to inform them it is considering this issue. The companies are being encouraged to participate in the public meeting and be prepared to supply scientific information they have collected on the safety of cloned animals.

Until the agency has scientific information on safety, it has asked the companies not to introduce these cloned animals, their progeny, or their food products into the human or animal food supply.