FDA reaches final conclusion that food from animal clones is safe

The Food and Drug Administration has issued final documents concluding that meat and milk from clones of cattle, swine, and goats—and from the offspring of clones—is as safe to eat as food from more conventionally bred animals.

In January, the FDA issued final versions of three documents outlining the agency's regulatory approach to animal cloning—a risk assessment, a risk management plan, and guidance for industry. The agency released drafts of the documents in December 2006 for public comment. In the intervening year, the FDA updated the risk assessment to include new scientific information. The information reinforces the conclusions of the draft documents regarding food safety, according to the agency.

In 2001, U.S. producers agreed to refrain voluntarily from introducing meat or milk from clones or clone offspring into the food supply until the FDA could evaluate the issue. Now, the Department of Agriculture is asking U.S. producers to maintain the existing voluntary moratorium until the USDA can consult stakeholders to ensure a smooth market transition.

The FDA is not requiring labeling or any other additional measures for food from clones of cattle, swine, and goats—or from clone offspring—because the agency has determined that food from these sources is no different than food from conventionally bred animals. If producers express a desire for voluntary labeling, the FDA will consider requests on a case-by-case basis to ensure compliance with statutory requirements for truth in labeling.

Because producers probably will keep most clones for breeding, the FDA does not expect clones to enter the food supply in any substantial numbers. Instead, clone offspring would be a more likely source of meat and milk for the marketplace. The agency deemed food from the offspring of clones of any traditional food animals to be suitable to enter the food supply.

The FDA continues to recommend that producers not introduce food from clones of species other than cattle, swine, and goats into the food supply. The agency did not reach a conclusion on the safety of food from clones of other animals, such as sheep, because of insufficient information.

The FDA's risk management plan outlines measures that the agency has taken to address the risks that cloning poses to animal health—risks that also exist to a lesser extent with other assisted reproductive technologies. The agency is working with scientific and professional societies with expertise in animal health and reproduction to develop standards of care for animals in the cloning process.

Additional information is available at fda.gov/cvm/cloning.htm.