F.D.A. Tentatively Declares
Food From Cloned Animals to Be Safe

ANDREW POLLACK and ANDREW MARTIN
New York Times 29dec2006

After years of delay, the Food and Drug Administration tentatively concluded yesterday that milk and meat from some cloned farm animals are safe to eat. That finding could make the United States the first country to allow products from cloned livestock to be sold in grocery stores.

Even if the agency’s assessment is formally approved next year, consumers will not see many steaks or pork chops from cloned animals because the technology is still too expensive to be used widely.

But the F.D.A.’s draft policy touched off an immediate storm of criticism from consumer groups, as well as some concerns from meat and dairy companies worried about consumer reaction.

“At the end of the day, F.D.A. is looking out for a few cloning companies and not for consumers or the dairy industry,” said Joseph Mendelson, legal director for the Center for Food Safety, an advocacy group.

Mr. Mendelson and other consumer representatives argue that the science backing the F.D.A.’s decision is shaky and that consumer surveys show that most people are opposed to cloning animals, let alone eating them. Some also said that cloning causes harm to the animals involved and could pave the way for human cloning.

Opponents hope to bring Congressional pressure to bear to derail the policy before it becomes final or at least to require that such foods be labeled so consumers can choose to avoid them. F.D.A. officials said that it was unlikely that labeling would be required because food from cloned animals is indistinguishable from other food, although a final decision about labeling has not been made.

Senator Patrick J. Leahy, Democrat of Vermont, yesterday called for a “careful, deliberative and open process” before cloned animals are approved for food.

The F.D.A.’s finding comes more than six years after the agency first decided to study the matter, after recognizing that the advent of cloned farm animals raised a food safety issue. After that study, the agency in 2003 gave a tentative approval to cloned animals for food. But the F.D.A. retreated after its own advisory panel found there was insufficient scientific backing for that conclusion.

This time, F.D.A. officials said they had substantial new data, which they presented yesterday in a nearly 700-page “draft risk assessment.”

The officials denied the contention from some critics that the policy was announced during a holiday week in order to reduce publicity, saying it had taken until now to analyze the data and obtain comment from other government agencies.

The assessment concluded that milk and meat from cloned cows, pigs and goats, and from their offspring, were “as safe to eat as the food we eat every day,” Stephen F. Sundlof, the F.D.A.’s chief of veterinary medicine, said in a telephone call with reporters.

Mr. Sundlof said that by law the agency could consider only the scientific issues, not consumer demand or the ethics of cloning.

While animal cloning has always been legal, since 2001 there has been a voluntary moratorium on the sales of milk or meat from such animals to give the F.D.A. time to study the matter. Some experts say that some products from clones or their offspring have probably nonetheless made their way into the food supply.

The moratorium will stay in place until the new policy is completed, after a 90-day period for public comment and additional time for the F.D.A. to review the comments. Mr. Sundlof said he could not say when the final policy would be ready, though it might be by the end of 2007.

Even then, the moratorium would remain for products from sheep, the F.D.A. said, because there was not enough evidence of their safety. No one has yet succeeded in cloning chickens or other poultry.

The finding was hailed by cloning companies, which have been struggling to build a business. It also drew praise from some farmers and breeders who have already made clones of their prized livestock but have had to pour milk down the drain and keep their meat off the market.

They say that cloning is just another breeding technique, like artificial insemination or in-vitro fertilization.

“This just sort of lifts the stigma of the clones,” said Bob Schauf, a Holstein breeder and dairy farmer in Barron, Wis., who had two of his prized cows cloned. He said his family and the families of his employees have been drinking the milk from those clones rather than see it go to waste. But dairy marketers have expressed concern.

A survey conducted last summer by the International Dairy Foods Association, an industry trade group, found that 14 percent of women would turn away from all dairy products if milk from clones were introduced into the food supply. The association surveyed women because its research has found them to be the main household decision makers on dairy products.

The American Meat Institute, while saying yesterday that cloning was safe, also urged the F.D.A. to be cautious about approval “if most consumers are unwilling to accept the technology.”

A poll this month from the nonprofit Pew Initiative on Food and Biotechnology found that while most consumers knew little about animal cloning, 64 percent said they were uncomfortable with it, with 46 percent saying they were “strongly uncomfortable.”

F.D.A. officials said no other country had yet approved food from cloned livestock, although some are considering it. That raised the prospect that American exports of milk or meat could be blocked by certain countries if they contain products from cloned animals. An official in the Washington delegation of the European Union said politicians and consumers in Europe would no doubt debate the issue.

Carol Tucker Foreman, director for food policy at the Consumer Federation of America, said consumer groups would ask food companies, retailers and restaurant chains to shun products from cloned livestock.

That raises the possibility that some food companies will label their products “clone free,” just as some now label milk as not coming from cows injected with growth hormone.

Cloning involves putting an animal’s DNA into an egg thats own DNA has been removed. The resulting embryo, after being implanted into a surrogate mother, makes a genetically identical copy of the original animal.

But even if two animals have identical genes, they can turn out differently if those genes are turned on or off at different times. And studies have shown that patterns of gene activity are different in embryos created by cloning compared with embryos created by the fusing of sperm and egg.

These differences are presumed to account in large measure for the low success rate of cloning. Fetuses can grow unusually large, posing a risk to the surrogate mother. Many clones die during gestation or shortly after birth. Some are born with deformed heads or limbs or problems with their hearts, lungs or other organs.

But the F.D.A. said that obviously sick and deformed animals were already barred from the food supply. It added that clones that survived past the first few days “appear to grow and develop normally” and that healthy adult clones were “virtually indistinguishable” from noncloned livestock, making their meat or milk safe.

The draft assessment based its conclusions on an extensive review of scientific literature on cloning as well as on studies, some done by cloning companies, comparing the composition of the milk, meat and blood of cloned animals and conventional animals.

Mr. Sundlof said the agency also found that cloning “poses no unique risks to the health of animals” beyond those seen with other forms of assisted reproduction such as in-vitro fertilization. The frequency of problems is higher with cloning, however, perhaps because it is a newer technology. The first cloned mammal, Dolly the sheep, was born in 1996.

The F.D.A.’s announcement, by paving the way for the end of the moratorium, could make it easier to persuade farmers and breeders to pay $15,000 to copy a prized bull or dairy cow.

“I think that this draft is going to provide the industry the comfort it needs,” said Mark Walton, president of ViaGen, a cloning company based in Austin, Tex., that has yet to turn a profit after five years.

Industry officials estimate there are now only about 500 or 600 cloned cows in the United States, out of tens of millions of beef and dairy cows. There are roughly 200 cloned pigs.

Experts say that cloning is too expensive to be used to make animals only to then grind them into hamburger or even to milk them. Rather, farmers and breeders are cloning prized livestock so they can then be used for breeding using more conventional means of reproduction.

That means that most food from cloning would come from the sexually produced offspring of the cloned animals. The F.D.A. said milk and meat from such offspring were safe, because any abnormalities in clones do not carry into the next generation.

The agency’s assessment did not include genetically modified animals, in which a foreign gene is introduced. The agency is still deciding whether to allow the first of those, a fast-growing fish, into the food supply.

source:  28dec2006

Squeamish Consumers May Balk As FDA Backs Cloned Meat, Milk 

JANE ZHANG, SCOTT KILMAN and LAUREN ETTER
Wall Street Journal 29dec2006

By declaring milk and meat from cloned farm animals safe to eat, federal regulators have opened the door to far-reaching changes in livestock production. But industry concerns about consumer squeamishness toward cloning suggest cloned beef and pork won't be on sale at supermarket meat counters anytime soon.

In a long-awaited decision announced yesterday, the Food and Drug Administration said it couldn't find any differences between meat and milk from healthy conventionally bred adult cattle, pigs and goats and that from healthy cloned animals and their offspring. As a result, the agency said it would probably allow the meat and milk of these cloned animals and their offspring to be sold without any special labeling to alert consumers.

Cloning, or producing an identical copy of an animal using the genetic material of the original, would give farmers a way to upgrade their livestock herds by replicating their prized animals. It would allow them to preserve valuable traits, such as high meat or milk production, superior fertility or disease resistance.

That could be a boon to the livestock industry, which so far has largely missed out on the biotechnology revolution that swept through plant agriculture a decade ago. Meatpackers, for example, might prefer to buy the offspring of a cloned pig with loins the perfect size for making pork chops or cattle with just the right amount of fat in the steak. Improved, consistent quality, in turn, could boost consumer demand.

Recent opinion polls show that most Americans know little about cloning but are wary of foods from cloned animals, with many citing ethical, religious and social concerns. Mindful of such reservations, large meat and dairy producers and their trade associations are taking a wait-and-see attitude. And a spokesman for Wal-Mart Stores Inc. said yesterday that the nation's largest food retailer has no plans to sell products made from cloned livestock.

"It's an issue of interest to us and the rest of the meatpacking industry, and something that we'll be following closely in the months ahead," said Archie Schaffer, spokesman for meat and poultry processor Tyson Foods Inc. Smithfield Foods Inc., the nation's largest pork producer, wouldn't comment yesterday, but in 2003, the company said it had "severe skepticism about the consumer reaction" to cloned animals.

The FDA, which has been studying the safety of food derived from cloned animals for four years, concluded that meat and dairy from cloned animals "are as safe as food we eat every day." The agency also indicated that if such foods go into production, it would be unlikely to recommend special labeling, the same policy it has adopted with genetically modified crops already on the market.

U.S. meat exports, already buffeted by concerns in some countries about mad-cow disease, could hang in the balance. The FDA has consulted major U.S. trading partners and agencies such as the U.S. Trade Representative on the cloning issue. But it isn't clear if that would help the U.S. livestock industry, should it embrace cloning, to win over foreign consumers.

Even though cloned animals exist in countries such as Japan, New Zealand and Australia, none have gone so far as the U.S. now has in nudging them toward the market. A French assessment of cloning reached the same conclusions as the FDA's, but that hasn't translated into public policy. European consumers, more than their American counterparts, are skeptical about genetically modified foods and biotechnology in general.

Canice Nolan, head of food safety, health and consumer affairs at the European Commission Delegation in Washington, said it was premature to talk about the impact of the FDA's decision on trade. However, he noted that cloning raises legal, ethical and social concerns.

According to a recent report to the European Union's executive arm by the Danish Centre for Bioethics and Risk Assessment, "Groups of citizens, and even some member states, would be likely to resist the import and/or marketing [labeled or unlabeled] of cloned animals and their products."

In South Korea, one of the largest export markets for U.S. beef, cloned foods "are not positive," said Sockjoong Yoon, minister for public affairs at the South Korean Embassy in Washington. Chong Ghee Ahn, the embassy's economic counselor, said it was too early to say what impact cloning might have on U.S. exports. However, he added that in the wake of mad-cow disease and avian flu, "Korean customers are getting very, very sensitive."

The FDA's safety assessment, which the agency calls "strictly a scientific evaluation," requires a 90-day period for public comment. Biotechnology experts said it would take at least three or four years after that for products made from cloned animals and their offspring to land on grocery shelves.

"There's no doubt that in the long run, probably in the immediate run, that this will be a substantial boon to producers of milk and meat, not only in the United States but around the world," said Val Giddings, a biotechnology consultant and a former senior staff geneticist at the U.S. Agriculture Department. "It frees the producers of milk and meat to use more fully and effectively the very best breeding stock available. They can use their healthiest animals, use animals with high resistance to disease."

Consumer and animal-rights groups said yesterday that consumers have little to gain from the FDA ruling, and that safety considerations alone don't make good public policy. "Cloning will not produce safer or cheaper milk and meat," said Carol Tucker-Foreman, director of food policy at Consumer Federation of America. "Having cloned cows produce more milk won't reduce milk prices."

The FDA said ethical issues were beyond the agency's jurisdiction, but it took pains to address consumer concerns. "Cloning poses no unique risks to animal health when compared to other assisted reproductive technologies," such as in vitro fertilization, said Stephen F. Sundlof, director of the FDA's Center for Veterinary Medicine.

The agency added that cloning was just another assisted reproductive technology — much like in vitro fertilization. While clones are more likely to have health problems at birth than traditionally bred animals, "They seem to become just as healthy and strong as other animals of the same age," it said.

Cloning of animals often has a low success rate, and unsuccessful procedures can cause abnormalities, premature deaths and other problems. Milk and meat from clones with the most severe cloning errors would be unlikely to enter the food supply, because they would "either die, fail to reproduce, or fail government examination and meat inspection," the FDA said. Moreover, because cloned animals are expected to be used mainly for breeding purposes, most of the products sold wouldn't be from cloned animals themselves, but from their offspring.

Modern livestock breeding already is highly regimented. Much of the beef and pork on the market today is the product of such techniques as artificial insemination, embryo transfer, embryo splitting and in vitro fertilization. That gives breeders control over the selection of parents.

Animal cloning remains relatively expensive, however. ViaGen Inc., a livestock cloning company based in Austin, Texas, charges $15,000 for the first copy of a cow, $12,500 for the second copy of the same animal, and $6,000 for the sixth and beyond. In the past two years, the five-year-old company has cloned 250 animals, including about 150 beef cattle, mainly for exhibition, and 100 pigs, mainly for research purposes, said Mark Walton, its president.

With a surge in demand, Mr. Walton said cloning prices would go down, eventually to as little as $5,000 to $6,000 per animal. Farmers could use more-conventional breeding methods to produce offspring from those cloned animals, and replace their breeding stock every few years. That could make cloning financially appealing for meat and milk producers, Mr. Walton said.

The FDA began looking at the safety of foods from cloned animals a few years after the successful cloning of Dolly the sheep in Scotland in 1997. The cloning prompted inquiries from companies planning to use the technique. In 2002, the FDA asked the National Academy of Sciences to look at the issue. A panel at the academy said foods from cloned animals and their offspring didn't present a food-safety concern, but recommended that the agency evaluate the composition of those foods.

The FDA assembled a committee that year to look at hundreds of studies on the issue, and cloning companies such as ViaGen and Cyagra Inc., of Elizabethtown, Pa., promised to send samples for research.

The bulk of samples didn't arrive until 2005 and were then sent to an independent lab at Cornell University and an Agriculture Department lab for controlled studies, extending the review process to this year. Because of public concern about cloning, the FDA waited until after it had briefed other agencies, including the USTR and the Agriculture Department, and U.S. trade partners on the issue before disclosing its findings.

—— Gary McWilliams contributed to this article.

Page A1

HOW CLONING WORKS

When scientists explain the practice of cloning livestock, they describe clones as genetic twins born at different times. Cloning companies say it's just another reproductive technology, such as artificial insemination. The scientific term for cloning is somatic cell nuclear transfer. To produce a clone, the nucleus of a donor egg is removed and replaced with the DNA of a cow, pig or other animal. A tiny electric shock coaxes the egg to grow into a copy of the original animal.

The first mammal cloned from an adult cell was Dolly the sheep in 1997. Dolly died prematurely in 2003 after developing cancer and arthritis.

-Associated Press

From Dolly to Today

Wall Street Journal 28dec2006

A brief review of the high points by cloning researchers around the world.

• February 1997 — Scotland's Roslin Institute announces its researchers have cloned a sheep from cells taken from an adult ewe. The sheep, called Dolly, was the first animal cloned in such a process; previous cloning had involved creating an animal from undeveloped fetal cells in a surrogate mother.
• August 1997 — Privately held cattle-breeding company ABS Global, of Wisconsin, announces it has cloned a calf from stem-cells removed from a cow fetus.
• July 1998 — Researchers at the University of Hawaii say they've successfully cloned dozens of mice.
• August 2000 — Boston biotech firm BioTransplant Inc. and Massachusetts General Hospital announce they have cloned a line of miniature pigs, with the intent of creating organs for transplant into humans.
• February 2002 — People familiar with a Texas A&M University research program known as CopyCat say the scientists successfully cloned a domestic cat in late 2001. The cat, whose birth was later confirmed, was named "cc:"
• March 2002 — French scientists announce the first clones of rabbits from adult cells, just in time for Easter.
• May 2003 — Scientists in Idaho, funded by a local grass and seed magnate, announce they have cloned a mule, a sterile hybrid normally produced by breeding a donkey and a mare. The animal, named Idaho Gem, narrowly nosed out competing efforts by teams in Texas and Italy to become the first cloned equine, an accomplishment much sought after by horse experts.
• August 2005 — South Korean scientists at the same university where the human embroyos were cloned say they've cloned the first dog, an Afghan hound named Snuppy.
• December 2006 — The Food and Drug Administration announces that milk and meat harvested from cloned cows, pigs and goats and their offspring is safe to eat and doesn't require special labeling.