FDA declares meat from cloned animals is safe
Posted: Wednesday, January 16, 2008
WASHINGTON (AP) -- Meat and milk from cloned animals is as safe as that from their counterparts bred the old-fashioned way, the Food and Drug Administration said Tuesday -- but sales still won't begin right away.
The long-awaited move came as welcome news to Sioux Center, Iowa-based Trans Ova Genetics, which has cloned about 250 prized cattle.
"We certainly are pleased," said Trans Ova President David Faber, who noted that previous reports by the National Academy of Sciences and others have reached the same conclusion. "Our farmer and rancher clients are pleased because it provided them with another reproductive tool."
The FDA decision removes the last big U.S. regulatory hurdle to marketing products from cloned livestock and puts the FDA in concert with recent safety assessments from European food regulators and several other nations.
"Meat and milk from cattle, swine and goat clones are as safe as food we eat every day," said Dr. Stephen Sundloff, FDA's food safety chief.
Regardless, it still will be years before many foods from cloned animals reach store shelves, for economic reasons: At $10,000 to $20,000 per animal, they're a lot more expensive than ordinary cows, meaning producers likely will use clones' offspring, not the clone itself, for meat.
And several large companies -- including dairy giant Dean Foods Co., which last month acquired Wells' Dairy's milk plant in Le Mars, Iowa -- have said they have no plans to sell milk or meat from cloned animals because of consumer anxiety about the technology.
But the government has asked animal cloning companies to continue a voluntary moratorium on sales for a little longer -- not for safety reasons, but marketing ones.
USDA Undersecretary Bruce Knight called it a transition period for "allowing the marketplace to adjust." He wouldn't say how long the moratorium should continue.
"This is about market acceptance," Knight added, who said he would be calling a meeting of industry leaders to determine next steps. But FDA won't require food makers to label if their products came from cloned animals, although companies could do so voluntarily if they knew the source. Last month, meat and dairy producers announced an industry system to track cloned livestock, with an electronic identification tag on each animal sold. Customers would sign a pledge to market the animal as a clone.
But that system is voluntary, and there is no way to tell if milk, for example, came from the daughter of a cloned cow.
"Both the animals and any food produced from those animals is indistinguishable from any other food source," Sundloff said. There's no technological way of distinguishing a food that's come from an animal that had a clone in its ancestry. It's not possible."
Trans Ova and Austin, Texas-based Viagen Inc. are the two main U.S. livestock cloning companies. Animals cloned by Trans Ova aren't raised for food production, but are of value to cattle breeders due to their genetic superiority and use for breeding. In addition, cloning is just one of Trans Ova's advanced reproductive services for breeders, which also include embryo transfers, including in-vitro fertilization, sexed-semen and genetic preservation.
The decision announced Tuesday by the FDA was long-expected, but controversial. Debate has been fierce within the Bush administration as to whether the FDA should move forward, largely because of trade concerns. Consumer advocates petitioned against the move, and Congress had passed legislation urging the FDA to study the issue more before moving ahead.
"The FDA has acted recklessly," said Sen. Barbara Mikulski, D-Md., who sponsored that legislation. "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.
"If you ask what's for dinner, it means just about anything you can cook up in a laboratory," said Carol Tucker-Foreman of the Consumer Federation of America, who pledged to push for more food producers to shun clones.
It was a day forecast since Scottish scientists announced in 1997 that they had successfully cloned Dolly the sheep. Ironically, sheep aren't on the list of FDA's approved cloned animals; the agency said there wasn't as much data about their safety as about cows, pigs and goats.
By its very definition, a successfully cloned animal should be no different from the original animal whose DNA was used to create it.
But the technology hasn't been perfected -- and many attempts at livestock cloning still end in fatal birth defects or with deformed fetuses dying in the womb. Moreover, Dolly was euthanized in 2003, well short of her normal lifespan, because of a lung disease that raised questions about how cloned animals will age.
The FDA's report acknowledges that, "Currently, it is not possible to draw any conclusions regarding the longevity of livestock clones or possible long-term health consequences" for the animal.
But the agency concluded that cloned animals that are born healthy are no different than their non-cloned counterparts, and go on to reproduce normally as well.
Journal business editor Dave Dreeszen contributed to this story.
The long-awaited move came as welcome news to Sioux Center, Iowa-based Trans Ova Genetics, which has cloned about 250 prized cattle.
"We certainly are pleased," said Trans Ova President David Faber, who noted that previous reports by the National Academy of Sciences and others have reached the same conclusion. "Our farmer and rancher clients are pleased because it provided them with another reproductive tool."
The FDA decision removes the last big U.S. regulatory hurdle to marketing products from cloned livestock and puts the FDA in concert with recent safety assessments from European food regulators and several other nations.
"Meat and milk from cattle, swine and goat clones are as safe as food we eat every day," said Dr. Stephen Sundloff, FDA's food safety chief.
Regardless, it still will be years before many foods from cloned animals reach store shelves, for economic reasons: At $10,000 to $20,000 per animal, they're a lot more expensive than ordinary cows, meaning producers likely will use clones' offspring, not the clone itself, for meat.
And several large companies -- including dairy giant Dean Foods Co., which last month acquired Wells' Dairy's milk plant in Le Mars, Iowa -- have said they have no plans to sell milk or meat from cloned animals because of consumer anxiety about the technology.
But the government has asked animal cloning companies to continue a voluntary moratorium on sales for a little longer -- not for safety reasons, but marketing ones.
USDA Undersecretary Bruce Knight called it a transition period for "allowing the marketplace to adjust." He wouldn't say how long the moratorium should continue.
"This is about market acceptance," Knight added, who said he would be calling a meeting of industry leaders to determine next steps. But FDA won't require food makers to label if their products came from cloned animals, although companies could do so voluntarily if they knew the source. Last month, meat and dairy producers announced an industry system to track cloned livestock, with an electronic identification tag on each animal sold. Customers would sign a pledge to market the animal as a clone.
But that system is voluntary, and there is no way to tell if milk, for example, came from the daughter of a cloned cow.
"Both the animals and any food produced from those animals is indistinguishable from any other food source," Sundloff said. There's no technological way of distinguishing a food that's come from an animal that had a clone in its ancestry. It's not possible."
Trans Ova and Austin, Texas-based Viagen Inc. are the two main U.S. livestock cloning companies. Animals cloned by Trans Ova aren't raised for food production, but are of value to cattle breeders due to their genetic superiority and use for breeding. In addition, cloning is just one of Trans Ova's advanced reproductive services for breeders, which also include embryo transfers, including in-vitro fertilization, sexed-semen and genetic preservation.
The decision announced Tuesday by the FDA was long-expected, but controversial. Debate has been fierce within the Bush administration as to whether the FDA should move forward, largely because of trade concerns. Consumer advocates petitioned against the move, and Congress had passed legislation urging the FDA to study the issue more before moving ahead.
"The FDA has acted recklessly," said Sen. Barbara Mikulski, D-Md., who sponsored that legislation. "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.
"If you ask what's for dinner, it means just about anything you can cook up in a laboratory," said Carol Tucker-Foreman of the Consumer Federation of America, who pledged to push for more food producers to shun clones.
It was a day forecast since Scottish scientists announced in 1997 that they had successfully cloned Dolly the sheep. Ironically, sheep aren't on the list of FDA's approved cloned animals; the agency said there wasn't as much data about their safety as about cows, pigs and goats.
By its very definition, a successfully cloned animal should be no different from the original animal whose DNA was used to create it.
But the technology hasn't been perfected -- and many attempts at livestock cloning still end in fatal birth defects or with deformed fetuses dying in the womb. Moreover, Dolly was euthanized in 2003, well short of her normal lifespan, because of a lung disease that raised questions about how cloned animals will age.
The FDA's report acknowledges that, "Currently, it is not possible to draw any conclusions regarding the longevity of livestock clones or possible long-term health consequences" for the animal.
But the agency concluded that cloned animals that are born healthy are no different than their non-cloned counterparts, and go on to reproduce normally as well.
Journal business editor Dave Dreeszen contributed to this story.
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Dick wrote on Jan 18, 2008 2:11 AM: