The Food and Drug Administration has found that meat or milk from clones of adult cattle, swine, and goats—and offspring of these clones—is as safe to eat as food from conventionally bred animals.
The agency recently requested public comment on three documents regarding the safety of animal cloning—a draft risk assessment, a proposed risk management plan, and a draft guidance for industry.
Dr. Stephen F. Sundlof, director of the FDA Center for Veterinary Medicine, said the agency analyzed hundreds of publications and other studies on the health and food composition of clones and clones' offspring.
A group of independent scientific experts in cloning and animal health reviewed the draft risk assessment. The document presents an overview of reproductive methods in animal agriculture, including cloning, along with extensive scientific information about risks from cloning for animal health and food consumption. The conclusions agree with the findings of a 2002 report from the National Academy of Sciences.
The FDA's proposed risk management plan addresses risks to animal health and potential remaining uncertainties about human food or animal feed from animal clones and offspring. The plan also outlines measures that the agency might take to address risks to animals in the cloning process. These risks occur with other reproductive technologies, though the frequency of anomalies is higher for cloning.
One measure could be that the FDA would work with scientific and professional societies with expertise in animal health and reproduction to develop care standards for animals in the cloning process. Although the agency does not have authority to address the ethics of animal cloning, the proposed risk management plan states that the FDA plans to provide scientific expertise to parties working on these issues.
The draft guidance for industry provides guidance for clone producers, livestock breeders, and farmers and ranchers purchasing clones. The document provides the FDA's current thinking on the use of clones and offspring in human food or animal feed. Because of limited data on sheep clones, the FDA recommends not using sheep clones for human food.
In the draft guidance, the agency does not recommend any special measures relating to human food use of offspring of clones of any species. Because of their cost and rarity, the FDA anticipates that clones will be similar to other elite breeding stock—which pass on naturally occurring, desirable traits such as disease resistance and higher quality meat to production herds. The FDA expects that almost all of the food that comes from the cloning process will come from sexually reproduced offspring and descendents of clones.
Dr. Sundlof said the agency continues to ask producers of clones and livestock breeders to refrain voluntarily from introducing food products from these animals into commerce so that the FDA can consider public comments and publish final documents on the subject.
The deadline for comments is April 3. Parties can submit comments electronically at www.fda.gov by clicking on Dockets under Reference Room, then clicking on Submit Electronic Comments. Parties can submit comments by mail to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should refer to docket number 2003N-0573.
More information is available at www.fda.gov/cvm/CloneRiskAssessment.htm.