Animal Clones Approved for Human Food
WASHINGTON, DC, January 15, 2008 (ENS) – The federal 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, the agency announced today.
There was insufficient information for the FDA to reach a conclusion on the safety of food from clones of other animal species, such as sheep.
The government’s decision drew criticism from the meat industry, farmers, animal protection groups and some lawmakers.
FDA today issued three documents on animal cloning outlining the agency’s regulatory approach – a risk assessment; a risk management plan; and guidance for industry.
The documents were originally released in draft form in December 2006. Since that time, the risk assessment has been updated to include new scientific information. The FDA says that new information reinforces the food safety conclusions of the drafts.
“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,” said Stephen Sundlof, DVM, PhD, director of FDA’s Center for Food Safety and Applied Nutrition. “Our additional review strengthens our conclusions on food safety.”
Eight cloned calves at the feeding
trough at the University of
Tennessee (Photo courtesy
UT Cloning Project)
The FDA says an animal clone is a genetic copy of a donor animal, “similar to an identical twin, but born at a different time.”
“Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA; cloning does not change the gene sequence, the agency explains.
Due to their cost and rarity, clones are intended to be used as elite breeding animals to introduce desirable traits into herds more rapidly than would be possible using conventional breeding.
The meat industry reacted to the agency’s decision with caution. Head of the American Meat Institute, the national trade association representing companies that process 70 percent of U.S. meat and poultry and their suppliers, said the organization would do its own evaluation.
“We appreciate FDA’s careful review of the science surrounding cloning,” said AMI Foundation President James H. Hodges. “Clearly, however, the cloning of animals is a new technology and our members will evaluate it, as well as consumer attitudes, very carefully. The meat industry has a history of analyzing the science surrounding technology and striving to meet consumer demand regarding our products. We intend to do so going forward.”
The National Farmers Union, with a membership of 250,000 farm and ranch families in all states, called the FDA decision “a bad idea.”
National Farmers Union President Tom Buis said, “In the face of ever-increasing food safety concerns, it is troubling to see the FDA approval of products from cloned animals to be sold to the public, when questions surrounding the health risks, legal implications and ethical concerns remain unanswered.”
“The economic implications of introducing products from cloned animals into the marketplace could be potentially devastating for family farmers and consumers,” Buis said.
He said there is no data to suggest any consumer demand for such products. So that consumers could know what they are buying, Buis urged Congress to pass the Cloned Food Labeling Act and direct the FDA to take the necessary steps to label cloned food products.
The FDA says it is not requiring labeling or any other additional measures for food from cattle, swine, and goat clones, or their offspring “because food derived from these sources is no different from food derived from conventionally bred animals.”
Various cuts of beef for sale in a
Pennsylvania market (Photo
by Winfried Mosler)
“Should a producer express a desire for voluntary labeling (e.g., “this product is clone-free”), it will be considered on a case-by-case basis to ensure compliance with statutory requirements that labeling be truthful and not misleading,” the FDA said.
The act to label cloned food was introduced by Senator Barbara Mikulski, as Maryland Democrat, who today scolded the head of the FDA, Dr. Andrew von Eschenbach, for the agency’s cloned food decision.
“The FDA has acted recklessly and I am profoundly disappointed in their rush to approve cloned foods. Dr. von Eschenbach, an experienced and respected scientist, should have known better. He said he is committed to reforming food and drug safety based on science,” said Mikulski.
“Just because something was created in a lab, doesn’t mean we should have to eat it. If we discover a problem with cloned food after it is in our food supply and it’s not labeled, the FDA won’t be able to recall it like they did Vioxx – the food will already be tainted,” she reiterated.
“The FDA has refused to listen to their own advisory board, to Congress, and to the American people, who pleaded for more scientific and economic research before allowing cloned food on U.S. shelves. What’s the urgency? We had time to do the work – now the FDA has rushed into a decision that could have dangerous consequences. The long term effects of these products are still unknown and could be harmful to consumers,” Mikulski said.
The farm animal protection organization Farm Sanctuary and the American Anti-Vivisection Society denounced the FDA’s decision.
Julie Janovsky, Farm Sanctuary’s director of campaigns, said, “It is an outrage that the FDA has misrepresented animal health and welfare implications. Cloning is a scientifically unsound and ethically challenged technology that has extremely disturbing welfare implications for animals.”
She pointed to scientific studies included in the FDA’s assessment showing that “28 percent of cow clone pregnancies suffer from hydrops, an often fatal condition in which the mother and/or fetus swells with fluid.”
“Over 50 percent of all calf clones suffer from Large Offspring Syndrome, in which the animal is grossly oversized” and displays other abnormalities that create “respiratory, cardiac, hepatic, renal, umbilical, and immunologic problems.”
“Even older clones who appear healthy have been known to develop ‘adult clone sudden death syndrome,’ which casts doubt that cloned animals can ever be considered healthy,” Janovsky said. “In contrast, these problems occur in less than five percent of conventional, noncloned animals, if ever.”
The FDA said the “science-based conclusions” in its risk assessment “agree with those of the National Academy of Sciences,” released in a 2002 report. “The assessment was peer-reviewed by a group of independent scientific experts in cloning and animal health. They found the methods FDA used to evaluate the data were adequate and agreed with the conclusions set out in the document.”
