On Jan. 15, the U.S. Food and Drug Administration announced that cloned livestock is safe to eat, and approved the sale of meat and milk from healthy cloned animals, despite a paucity of safety studies, congressional roadblocks and a clear consumer mandate against such products in the food supply.
The agency's final risk assessment, which ran to almost 1,000 pages, concluded, "Meat and milk from cattle, swine and goat clones are as safe as food we eat every day," according to Stephen Sundlof, director of the Center for Food Safety and Applied Nutrition.
The next day, the U.S. Department of Agriculture asked farmers to observe an ongoing "voluntary moratorium" on releasing cloned animal products into the market, a sign that the cloning issue remains divisive even within U.S. regulatory agencies.
"This flies in the face of what Congress asked for and what consumers demand," said Michael Hansen, Ph.D., senior scientist with Consumers Union, a nonprofit based in Yonkers, N.Y. "Poll after poll shows that consumers either won't eat it or want labeling, but FDA basically caved in to pressure from the biotech industry and a handful of cloning companies."
In December, the Senate asked the FDA to delay approval until completion of two studies: a National Academy of Sciences report on safety issues, and a USDA Economic Research Service examination of economic impacts of cloned food. It is likely, for example, that European Union consumers will reject all cloned products. Instead, Hansen said, the FDA issued a decision based on scanty science, ignoring issues of animal welfare.
"Ninety-five percent of implanted clones don't make it," Hansen said. "Most die before birth, and the ones that live have all sorts of health problems. Yet they couldn't conclude that the technology is unsafe for animals, despite data on high rates of death and deformities." Because of their weakened immune systems, many clones require large doses of antibiotics, while the surrogate parents require hormones to prepare them for implantation.
"We don't know if the indirect results of animal cloning will have an impact on human health," said Steven Hoffman, managing director of the Organic Center, a Boulder, Colo.-based non-profit science and research foundation. "On an animal welfare level, cloned animals are unhealthy animals. On a human safety level, we believe there are insufficient studies to determine whether there's a problem."
According to Hansen, the FDA's safety conclusions on milk come from 43 cow clones, and on meat from 16 cow clones and just five pig clones. "On that small sample size, they concluded that meat and milk from all clones and their progeny is safe," Hansen said.
When cloned meat and milk begins to enter the market — and there are reports that cloned bull semen has already been used to produce offspring later sold for processing — the FDA has already determined that no labeling of cloned products will be required.