Hello Dolly? FDA Calls Food from Clones Safe

WASHINGTON—FDA announced after extensive study and analysis it concluded cloned animals are as safe a food source as their conventionally bred counterparts. Via the release of three documents—a risk assessment, a risk management plan and a guidance for industry—the agency opened the door for meat and milk from clones of cattle, swine and goats, as well as the offspring of clones from any species traditionally consumed as food. However, it did not uphold the safety of foods from cloned sheep, citing insufficient data.

FDA commissioned the National Academy of Sciences (NAS) to look into any possible safety issues with using bioengineered and cloned animals in the country's food supply. NAS consulted experts in the field and held workshops, leading to a final report, "Animal Biotechnology: Science-Based Concerns", in August 2002. The report concluded food products made from cloned animals posed no safety concerns, but the group urged further investigation to confirm the findings. These findings formed the basis of FDA's risk assessment on the matter.

The risk management plan outlines the agency's measures to address the risks of cloning production on the cloned animals, risks FDA said have been observed in other assisted reproductive technologies currently used in common agricultural practices in the United States. While the agency is not responsible for ethical issues related to animal cloning for agricultural purposes, it is currently working with scientific and professional societies with expertise in animal health and reproduction to develop standards of care for animals involved in the cloning process.

FDA geared its guidance to industry to clone producers, livestock breeders, and farmers and ranchers purchasing clones. FDA said it does not recommend any special measures relating to the use of the cloned animals as food ingredients. The agency further said it will not require labeling or any other additional measures for food from cattle, swine and goat clones, or their offspring. It added any use of voluntary labeling (e.g., "this product is clone-free") will be considered on a case-by-case basis "to ensure compliance with statutory requirements that labeling be truthful and not misleading."

FDA stated it does not expect a significant number of cloned animals to hit the food market, as these animals are used primarily to breed. It noted 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 assured. "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."

While the Humane Society and others have asked FDA to ban foods made from cloned animals, out of concern for the animals' safety, certain areas of the food industry have additional concerns. Following FDA's press conference on the safety of cloned animals in foods, the Organic Trade Association (OTA) reassured industry and the public that meat, milk and other products produced from cloned animals will not be allowed in products sold as organic in the United States.

"The organic business community has never supported cloning animals as a part of the organic process," said Caren Wilcox, executive director of OTA. "Organic animal products will not come from cloned animals. In the future, consumers who seek to avoid cloned meat, dairy or other animal products should look for the organic label on products."

In fact, OTA noted the USDA-enforced national organic standards require organisms be developed and grown by systems compatible with natural conditions and processes, including the breeding and raising of animals for meat and for dairy or other animal production. In a release following the FDA cloning announcement, the National Organic Program (NOP) confirmed "cloning as a production method is incompatible with the Organic Foods Production Act (OFPA) and is prohibited under the regulations." While this excludes animals produced via cloning technology, the final word on the use in organics of offspring from cloned animals has not been filed, according to NOP, which is preparing a public rulemaking based on the recommendations by the National Organic Standards Board (NOSB).

Despite the green light from FDA, clone foods might not attract the majority of consumers, according to the Cornucopia Institute, which strives for economic justice for the family-scale farming community and runs the Organic Integrity Project, a watchdog program. Mark A. Kastel, senior farm policy analyst at Cornucopia, noted a recent poll conducted by the Food Information Council found 58 percent of Americans would be unlikely to buy meat or milk from cloned animals, even with FDA's safety endorsements. He further reported high percentages of cloned cattle, sheep and mice exhibit some abnormality, with a large percentage of the animals dying during gestation or shortly after birth. Such defects include grossly oversized calves, enlarged tongues, squashed faces, intestinal blockages, immune deficiencies and diabetes. He concluded fears over how this technology affects animals and the inclusion of such animals in the human food supply will drive consumers to organics.

"The arrogance of some in corporate agribusiness will likely, once again, drive consumers to purchase organic food, the last bastion of authenticity in the human food chain," Kastel said. "Just as in the dairy industry's adoption of genetically engineered bovine growth hormone (rBGH/rBST), if the meat industry circles the wagons, they will drive consumers to the natural food cooperatives and grocers stocking organic meat."

While the Grocery Manufacturers Association and manufacturers such as Hormel Foods support the FDA allowance of cloned meat and milk in foods, Whole Foods Market and natural and organic food producers such as Dean Foods vowed to remain clone-free. Also, the Center for Food Safety, a consumer-advocacy group, filed a petition asking FDA to regulate cloned animals as an animal drug, similar to how it is considering regulation of genetically modified animals.

Regardless of how cloning-based foods perform in the United States, companies exporting internationally, especially to Europe, will face an even more resistant consumer market. EU regulators and consumers have historically rejected technologically modified foods and already ban most U.S.-born meats because of hormone use. However, in its initial assessment on food from cloned animals, the European Food Safety Authority (EFSA) upheld the idea cloned animals are safe to eat, although its final decision is not expected for several months.