Something’s scary in the dairy. The FDA OKs food from cloned animals, despite scientific concern and a public outcry.

The Food and Drug Administration (FDA) announced last December that the agency will likely approve the sale of cloned foods this year. The FDA’s action flies in the face of widespread scientific concern about the risks of food from clones, and ignores the animal cruelty and troubling ethical concerns that the cloning process brings. What’s worse, the FDA indicates that it will not require labeling on cloned food, so consumers will have no way to avoid these experimental foods. The FDA is accepting public comments on its decision until April 2.

Cloning first succeeded in producing a live birth with the famed sheep clone Dolly in 1997, and has since been used with many other animal species, including dairy cows and beef cattle, poultry, hogs and other livestock. But after the hype, few followed the story of Dolly’s untimely demise. Just six years old when she was euthanized (sheep of Dolly’s breed generally live to 11 or 12), Dolly suffered from premature arthritis and lung disease usually seen in much older animals.

Sadly, Dolly was hardly unique among cloned animals. Incidents of unusual health problems, chronic illnesses and sudden unexpected deaths plague the cloning industry. Ian Wilmut, the lead scientist responsible for creating Dolly, has warned that even small imbalances in a clone’s hormone, protein or fat levels could compromise the safety of its milk or meat, saying, "If companies start marketing this food and there are problems it will bring the whole technology into disrepute."

Despite this track record of failure and concern about safety, some livestock breeders are using cloning in the hope that the technology will enable them to generate identical copies of prized animals with favorable characteristics. For example, cows that produce high quantities of milk have been cloned in hopes of producing dependable lines of high-yielding milk cows. Since as early as 2001, cloned cows have been producing milk on American dairy farms. The only barrier to this cloned milk entering the food supply is a voluntary agreement between industry and the Food and Drug Administration (FDA), which has requested that food products from clones be kept off the market until the agency’s "guidelines" are developed.

While the biotechnology industry has proclaimed the safety of their cloned food products, few food safety studies have been conducted. In fact, scientists have yet to conduct any large-scale, comprehensive, long-term food safety study of cloned animals. A 2004 National Academy of Sciences study noted that protocols for assessing food safety issues in cloning are complex and undeveloped, and stated that "a national system" to identify and track food from animal clones "must be implemented" before cloned foods are marketed. Moreover, the Academy observed that small sample sizes, limited health and production data and rapidly changing cloning protocols make it difficult to draw conclusions regarding the safety of milk, meat or other products from cloned animals.

The FDA has wholly ignored the animal cruelty issues inherent in cloning. Surrogate cows must be used to produce clones, and these surrogates suffer from high rates of late-term abortion, early prenatal deaths and grossly oversized calves; they often have severe pregnancy complications and caesarian births. Cloned offspring suffer from common defects such as enlarged tongues, squashed faces, intestinal blockages, immune deficiencies and diabetes. These are not unusual side effects, but a certain inhumane cost of this unseemly cloning business: cloning failure rates have been reported as high as 98 percent, and one study found that with cloning "64 percent of cattle, 40 percent of sheep and 93 percent of mice exhibit some form of abnormality." The Humane Society of the United States has condemned cloning, citing the increased animal suffering and noting that cloning "reinforces the perception of animals as disposable, manufactured commodities."

Leading cloning scientists say that even seemingly healthy clones are likely to carry genetic abnormalities. These abnormalities could have food safety consequences, but almost no studies have looked at this problem. The National Academy of Sciences found, "There is currently no data to indicate whether abnormalities in patterns of gene expression persist in adult clones and are associated with food safety risks." Wilmut has pointed out that while such studies have not been done on adult cloned livestock, studies of cloned mice have shown that such abnormalities do persist.

To manage the high pregnancy failure rate in cloning, scientists often inject surrogate cows with massive doses of hormones. To live with immune deficiencies, cloned offspring may be given high doses of antibiotics and other veterinary drugs. Commercialization of cloning would almost certainly increase levels of veterinary hormones and antibiotics in the human food supply, yet the FDA has failed to assess the food safety issues of such an increase.

Famed sheep clone Dolly suffered from premature arthritis and lung disease usually seen in much older animals.

Cloning is an essential technology for the genetic engineering industry. Biotech companies use cloning to replicate copies of their gene-altered (transgenic) animals, since normal reproduction might not recreate the desired genetic alteration. Numerous companies are already producing cows, goats, chickens, pigs, poultry and other genetically engineered animals to produce experimental foods or drugs. With such genetic engineering will come all of the health, food safety and animal welfare issues of cloning, with the additional environmental concerns posed by the creation of engineered animals that may unexpectedly breed with natural populations.

Animal cloning is also seen by many critics as a "slippery slope" to human cloning. In fact, the two leading animal cloning companies were created by Geron and Advanced Cell Technology (ACT), the two companies most involved in human embryo cloning experiments. The animal cloning firms, Cyagra (created by ACT) and ViaGen (created by Geron and Exeter Life Sciences) contributed more than a quarter of the data the FDA relied on for its assessment of clone safety.

In response to the FDA’s looming decision on food from animal clones, U.S. Senator Barbara Mikulski (D-MD) recently introduced the Cloned Food Labeling Act, SB 414. The Senator says, "The public deserves to know if their food comes from a cloned animal. My legislation will help the American public make an informed decision. I am strongly opposed to the FDA approving meat and milk products from cloned animals for human consumption. If cloned food is safe, let it onto the market, but give consumers the information they need to avoid these products if they choose to. We need to let Americans—many of whom find this repugnant—speak with their dollars and choose the food that they feel confident is safe."

The Center for Food Safety has called on the FDA to ban the use of clones in food production until the food safety and animal cruelty problems in cloning have been resolved, and until public discussions have addressed the troubling ethical issues that cloning brings. CFS has also called on the FDA and Congress, in the event that these pre-conditions can be met, to require labeling of food from animal clones.

HEATHER WHITEHEAD is the True Food Network Director at the Center for Food Safety, which works to protect human health and the environment by curbing the

proliferation of harmful food production technologies and by promoting organic and other forms of sustainable agriculture.

CONTACTS: Center for Food Safety; The True Food Network

Send your comment on food animal cloning to the FDA by April 2, 2007

To contact your Senators and urge their support of the Cloned Food Labeling Act