Meat and milk from cloned animals and their offspring are as safe as the natural versions, the
declared Tuesday, clearing the way for such products to enter the food supply without special labeling.
In releasing its 968-page final risk assessment on the safety of cloning technology, the FDA asked producers to continue keeping cloned cattle, pigs and goats out of the food supply during a transition period of unspecified length.
But the federal agency said that products from the offspring of clones could be sold to the public immediately.
"Meat and milk from clones of cattle, swine and goats and their offspring are as safe to eat as food from conventionally bred animals," said Randall Lutter, the FDA's deputy commissioner for policy.
Government scientists said they did not have enough information on cloned sheep or other species to rule that they were safe to eat.
Initially, only a small amount of steaks, pork and dairy products derived from clones will become available in grocery stores, industry executives said. But over the next three to five years -- after ranchers have time to clone their most prized animals and those clones are able to breed -- the products will become routine on store shelves, they said.
The decision, at least seven years in the making, was based on hundreds of studies conducted around the world that found that meat and milk from clones is biologically indistinguishable from meat and milk sold to the public today.
Critics remain unconvinced. "Just because something was created in a lab doesn't mean we should have to eat it," said Sen. Barbara A. Mikulski (D-Md.), who had pressed the FDA to conduct further studies on the safety of clones and will now push for mandatory labeling. "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."
The FDA said it would continue to monitor the safety of cloned food and would adjust its policy if necessary.
Consumer advocates also expressed outrage. "FDA's action has placed the interests of a handful of biotech firms above those of the public they are charged with protecting," said Andrew Kimbrell, executive director of the nonprofit Center for Food Safety in
The risk assessment said that "cloning raises many ethical and economic concerns" that are important to the public but that the FDA's task was to focus on the science.
Even with the FDA's endorsement, producers face an uphill battle persuading consumers to accept the new technology.
A survey last year by the International Food Information Council, which is supported by the food, beverage and agricultural industries, found that 22% of U.S. consumers had a favorable view of animal cloning, compared with 50% who were opposed. If deemed safe by the FDA, support for using cloned animals as food rose to 46% -- a substantial increase, but still a minority of consumers.
Cloning advocates acknowledge that the technology has a "yuck factor" that has been difficult to shake.
"The entertainment industry has used the word 'clone' in a negative context," said Jerry Baker, chief executive of the Federation of Animal Science Societies in
, Ill. "That's a hard one for us to overcome, but we have to continue to try."
Scientists frequently point out that clones are not
mutants but identical
of naturally produced animals -- just born at a different time.
To make a clone, scientists remove the
from the nucleus of a normal egg and replace it with DNA from a prized animal. A tiny electric shock induces the egg to grow into a copy of the original animal. No new
are introduced or modified in the process.
"We're not out to create some kind of abnormal individual," Baker said.
Producers, like Limousin cattle rancher Larry Coleman of Charlo, Mont., said they simply wanted to extend the breeding capabilities of their most superior animals.
Coleman spent $60,000 for three clones of his late prize bull, First Down, whose semen used to sell for as much as $700 a vial. By offering semen from the clones, Coleman hopes to multiply his sales while offering breeders the same high-quality product at a cheaper price.
Because he abided by the FDA's voluntary moratorium against introducing meat and milk from clones and their offspring into the food supply, Coleman waited years to recoup his investment. Now he intends to sell semen from one of the clones, Second Down, during the spring breeding season for as little as $20 a vial.
"It's sure going to make a lot of difference that we got a green light," said Coleman, who has eaten plenty of beef sired by Second Down.
The livestock industry has a long record of using a variety of reproduction technologies to improve the quality of its herds.
Breeders began using artificial insemination in the 1960s. Then they moved on to more sophisticated techniques like in vitro fertilization and embryo splitting, which turns a single genetically desirable animal into twins.
The first cattle clones were born in 1998, followed by pigs in 2000.
"Most consumers don't go to the grocery store wondering if artificial insemination was used to produce their pork chop, or whether their milk came from a dairy cow that was produced through embryo transfer," said Mark Walton, president of Austin,
-based ViaGen Inc., which provided more than 400 cloned animals to government scientists.
The FDA began studying the safety of cloned food in 2001. It commissioned a report from the National Academy of Sciences, which found that the risk presented by cloned animals and their offspring was small.
A 2006 study by scientists from the FDA's Center for Veterinary Medicine scrutinized the vitamins, minerals, proteins, amino acids, fat, water and carbohydrate content and found no "nutritionally or toxicologically important differences." Clones are more likely to die in utero or shortly after birth and to have
. They also pose a risk to their surrogates because they tend to be larger than their naturally conceived counterparts.
But the clones that survive into adolescence are just as healthy as other animals, according to the 2006 study. Screening methods already in place would prevent clones that are sick or abnormal from entering the food supply, so no additional safeguards should be required, the scientists said.
Few clones are likely to become burgers or bacon because they cost far more to produce than they would be worth at a slaughterhouse. ViaGen, for example, currently charges $17,500 to clone a single cow and $4,000 for a pig. It is primarily their offspring that will wind up on dinner tables.
"Most consumers will never eat a cloned animal," said Gregory Jaffe, director of the Biotechnology Project at the Center for Science in the Public Interest in Washington.
Only a fraction of the 97 million cattle in the U.S. are even candidates for cloning.
"I would love to project that this is just going to blow the doors off our business," Walton said. He predicted that over the next five years, only a few hundred -- and certainly no more than 1,000 -- clones would be born in a single year.
At the request of the food industry, cloning firms have pledged to carry out a voluntary tracking program to ensure the animals they produce don't wind up on plates where they aren't wanted.
ViaGen and Trans Ova
of Sioux Center,
, devised a system to track every cloned animal with a unique electronic identification tag affixed to the animal's ear, Walton said. The companies will enter each cloned cow and pig into a registry and charge their clients a deposit -- equivalent to about twice the animal's market value -- which will be returned after they demonstrate that their animals were sold to companies that accept cloned animals.
The system does not include tracking for the offspring of clones. "The progeny of clones aren't clones, so there's really nothing to track anyway," Walton said.
Cloning opponents have also raised concerns about the ability of U.S. producers to export meat and milk to foreign markets without mandatory labeling so that consumers can avoid cloned products.
Europeans in particular have resisted attempts by American companies to sell them genetically modified foods. But last week, the European Food Safety Authority gave a preliminary endorsement to the technology.