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The U.S. Food and Drug Administration issued three documents on the safety of animal cloning - a draft risk assessment; a proposed risk management plan; and a draft guidance for industry.
The draft risk assessment finds that meat and milk from clones of adult cattle, pigs and goats, and their offspring, are as safe to eat as food from conventionally bred animals. The assessment was peer-reviewed by a group of independent scientific experts in cloning and animal health. They agreed with the methods FDA used to evaluate the data and the conclusions set out in the document.
The proposed risk management plan addresses risks to animal health and potential remaining uncertainties associated with feed and food from animal clones and their offspring.
The proposed plan outlines measures that FDA might take to address the risks that cloning poses to animals involved in the cloning process. These risks all have been observed in other assisted reproductive technologies currently in use in common agricultural practices.
The draft guidance for industry addresses the use of food and feed products derived from clones and their offspring. The guidance is directed at clone producers, livestock breeders, and farmers and ranchers purchasing clones. It provides the agency's current thinking on use of clones and their offspring in human food or animal feed.
In the draft guidance, FDA does not recommend any special measures relating to human food use of offspring of clones of any species. Because of their cost and rarity, clones will be used as are any other elite breeding stock - to pass on naturally-occurring, desirable traits such as disease resistance and higher quality meat to production herds. Because clones will be used primarily for breeding, almost all of the food that comes from the cloning process is expected to be from sexually-reproduced offspring and descendents of clones, and not the clones themselves.
FDA is seeking comments from the public on the three documents for the next 90 days. For more information, visit www.fda.gov/cvm/CloneRiskAssessment.htm.
