FDA Issues Documents on the Safety of Food from Animal Clones

(FDA: Rockville, Maryland) -- After years of study and analysis, the Food and Drug Administration has concluded that meat and milk from clones of cattle, swine, and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals.

FDA issued three documents on animal cloning outlining the agency’s regulatory approach: a risk assessment, a risk management plan, and guidance for industry.

The risk assessment document presents an overview of assisted reproductive technologies widely used in animal agriculture, the extensive scientific information available on the health of animal clones and their sexually reproduced offspring, and an assessment of whether food from clones or their sexually reproduced offspring could pose food consumption risks different from the risks posed by food from conventionally bred animals. The science-based conclusions agree with those of a 2002 National Academy of Sciences report. The assessment was peer-reviewed by a group of independent scientific experts in cloning and animal health who found the FDA’s evaluation methods adequate and agreed with the conclusions in the document.

“After reviewing additional data and the public comments in the intervening year since the release of our draft documents on cloning, we conclude that meat and milk from cattle, swine, and goat clones are as safe as food we eat every day,” says Stephen F. Sundlof, director of the FDA’s Center for Food Safety and Applied Nutrition. “Our additional review strengthens our conclusions on food safety.”

The risk management plan outlines measures that the FDA has taken to address the risks to animals involved in the cloning process. Currently, the FDA is working with scientific and professional societies to develop standards of care for animals involved in the cloning process. Although the agency is not charged with addressing ethical issues related to animal cloning for agricultural purposes, the FDA plans to continue to provide scientific expertise to interested parties working on these issues.

The FDA, in the guidance for industry document, does not recommend any special measures relating to the use of products from cattle, swine, or goat clones as human food or animal feed. Because insufficient information was available on clones from other species, such as sheep clones, to make a decision on food consumption risks, the guidance recommends that food products from clones of other species continue to be excluded from the human food supply. The guidance states that food products from the offspring of clones from any species traditionally consumed for food are suitable to enter the food and feed supply.

For more information, visit www.fda.gov/bbs/topics/NEWS/2008/NEW01776.html.

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