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F.D.A. Says Food From Cloned Animals Is Safe

New York Times, January 16, 2008

After years of debate, the Food and Drug Administration on Tuesday declared that food from cloned animals and their progeny is safe to eat, clearing the way for milk and meat derived from genetic copies of prized dairy cows, steers and hogs to be sold at the grocery store.

Rancher: Cloning equals better beef product

By VINCE DEVLIN of the Missoulian



Charlo rancher Larry Coleman prepares a shot Thursday afternoon for one of the cows in the herd at the Coleman Limousin Ranch. Coleman invested in cloning a prize bull in 1999 and is still awaiting FDA approval to market meat products from cloned animals. The agency moved a step closer to full approval last week.
Photo by KURT WILSON/Missoulian






The Horse.Com Online News, April 27, 2005 Article # 5729


American Horse Cloning Project Successful

America's first cloned horse turned six weeks old today, according to Texas A&M University (TAMU) researchers who partnered on the successful cloning venture with French scientist Dr. Eric Palmer of Cryozootech. The colt, named "Paris Texas," was produced from skin cells of a European performance stallion, and the active colt is healthy and steadily growing at TAMU.



Above, North America's first horse clone, "Paris Texas," and the grade mare who carried him to term, "Greta." Below, Drs. Katrin Hinrichs of Texas A&M and Eric Palmer of Cryozootech, who collaborated on the cloning project.


Katrin Hinrichs, DVM, PhD, Dipl. ACT, professor in the College of Veterinary Medicine at TAMU, led the cloning team on the project. She described Paris Texas as follows: "He's bay with a big white blaze, beautiful eyes, and four white stockings. He's real forward, a real nice foal. Everything is completely normal about him.

"Dr. Palmer took a small piece of skin from the donor animal and grew the cells up in culture and froze them, and he shipped them to us," said Hinrichs. "We did the cloning procedure here, cultured the embryo, and transferred it to one of our recipient mares, who foaled here in the hospital."

The owner of the donor horse from which skin cells were used to produce the clone wishes to remain anonymous. Cryozootech has cells from a variety of high-performance horses in Europe. Since researchers at TAMU were already doing the cloning research, a natural partnership formed between the French company and TAMU to complete this project. Paris Texas is the fourth equine clone to be born in North America, but he is the first horse foal (the other three were mules) and the first to be cloned from adult cells in North America. The mule clones were produced from cells from a fetus.

The TAMU team does all of its cloning work in vitro, or in the laboratory. Rather than getting oocytes (eggs) from mares right before they ovulate (the procedure used to produce the mule clones), TAMU researchers harvest oocytes from mares at other points in the cycle and mature them in an incubator. The scientists then perform nuclear transfers, in which they remove the nucleus from an egg cell (containing the cell's genetic material) and place a donor cell into the enucleated egg. The eggs are then activated, or stimulated to start dividing to form an embryo. Resulting cloned embryos are cultured in the laboratory for seven days, and once they are deemed ready, the scientists transfer  them nonsurgically into the recipient mare's uterus just as they would in normal embryo transfer procedures.

About 400 oocytes were cultured during the TAMU project, and the cloning process produced six embryos. Only one pregnancy resulted, and this was carried to term. The grade mare that carried the clone (Greta) has been a part of the reproduction herd at TAMU for about four years.

The colt will be used as breeding stock in Europe. "We're looking for a way to save valuable genetics," said Hinrichs. But cloned foals are unlikely to be competitors. "There are so many variables in the environment that a cloned foal has-Paris Texas  was in a petri dish in an incubator for the first seven days of his life," she added. "He was small at birth--about 60 pounds. Sometimes smaller foals don't achieve the adult proportions that they would have. But this horse, genetics-wise, should produce exactly the same sperm and should be able to sire foals with the same genetic makeup as the donor animal."

TAMU has several pregnancies from cloned embryos that are currently gestating and due for arrival in 2006. All were produced using donor cells from American horses. Hinrichs said, "We're so excited about what we're learning about the horse oocyte. We're looking at different methods for treating the donor cells before the nuclear transfer procedure and activating the egg afterward, looking at more ways to build on our results of the study that produced Paris Texas."


Los Angeles Times, Feb. 10, 2005


The Beef About Clones

By Karen Kaplan, Times Staff Writer


CHARLO, Mont. — After 30 years of raising cattle the old-fashioned way, Larry Coleman decided six years ago to plunk down $60,000 to clone the best Limousin breeding bull these parts had ever seen.

First Down, a hulking black creature that died in 1999, produced semen that sold for as much as $700 a vial — and he filled thousands of them. Now a new First Down, along with fellow clones Second Down and Third Down, are ready to kick off their careers as professional sires. Second Down has already been relocated to a semen collection facility in Billings.

Fliers have been printed. A three-ring binder contains orders from eager customers. Thousands of semen straws are waiting in a freezer.

And waiting … and waiting … and waiting.

"I thought for sure we'd have our investment back by now," Coleman said.

Blocking Coleman's leap into the cloning revolution is the Food and Drug Administration, which despite four years of study has yet to rule that products from cloned animals are safe to eat.

Thousands of other ranchers are in similar straits, holding back prospective steaks and milk as the FDA studies the issue, although some meat is quietly making its way to the dinner table.

The main concern is not the clones themselves, which are too precious to butcher for burgers. Rather, the government is worried that milk from clones or meat from their offspring might pose some unknown health risk.

The FDA did its own study in 2003 and found that "food products derived from animal clones and their offspring are probably as safe to eat as food from their non-clone counterparts."

But the ranchers acknowledge there is an inescapable queasiness about cloning that complicates the government's decision. Even though the first animal clone — Dolly the sheep — was born nearly a decade ago, the public still has a hard time grappling with the new science.

It's even harder to think about eating it.

According to a survey last year by the International Food Information Council, a trade group, 62% of consumers said they would be "very unlikely" or "somewhat unlikely" to buy meat, milk and eggs from cloned animals.

A separate poll conducted by Gallup found that 64% of American consumers believed cloning animals was "morally wrong."

As Carol Tucker Foreman, director of the Consumer Federation of America's Food Policy Institute, explained: "The yuck factor is very large."


Lounging in a slushy pen with a few dozen other cattle, First Down and Third Down don't seem like much of a threat to the nation's food supply.

Their faces and hindquarters caked in mud, they look pretty much like all the other bulls — except bigger.

Coleman can't help but think of the original when he looks at the two clones.

"Every wrinkle — everything about them, even the disposition and character — are the same," he said nostalgically.

The spirit of the first First Down looms large on the Coleman ranch.

A metal cutout of his blocky silhouette is soldered to the family's mailbox. His jet-black likeness adorns the tan baseball caps worn by the Coleman clan. More than 5,500 calves are registered as his offspring.

When he was born on the ranch in 1994, First Down was small like a puppy dog, hardly remarkable. But he soon outgrew his fellow calves. His yearling weight of 1,580 pounds made him several hundred pounds heavier than many adult Limousin bulls.

In the rating system for breeding bulls, First Down had phenomenal stats. He ranked in the top 1% of his breed in terms of growth, docility, muscle marbling and scrotum size, a measurement used to predict the fertility of his daughters.

"The genetics of a bull like that are of extreme value to our population," said Kent Andersen, executive vice president of the North American Limousin Foundation in Englewood, Colo.

He declared First Down the "most influential" Limousin in the country since the first bulls arrived from France in 1971.

He couldn't have been born at a better time.

Coleman and his wife of 35 years, Anita, live a modest life in a town of 439 where the lone grocery store sells farming magazines at the checkout stand. He manages about 800 head of cattle on land homesteaded by his grandfather in 1908. Larry's father, brother, nephew and one son all live within a few miles.

In the mid-1980s, a depressed farm economy forced Coleman's ranch into bankruptcy.

First Down saved them. Coleman entered 10 of First Down's sons in the 1998 stock show and won the grand champion prize. Animals sired by First Down commanded a hefty premium at auction.

"He was our million-dollar bull," Coleman said, exaggerating slightly.

The idea of cloning First Down was not obvious to Coleman. The technology was still experimental at the time: The first calves cloned from an adult cow were born in Japan in 1998. But as word of the breakthrough spread, suggestions made their way to Charlo.

A few months before First Down died of natural causes, Coleman sent a small piece of the bull's ear to Infigen Inc., a biotech company in DeForest, Wis.

To clone an animal, scientists start with a piece of ear skin and mince it up in a lab. Then they induce the cells to divide in a culture dish until they forget they are skin cells and regain their ability to express all of their genes. Meanwhile, the nucleus is removed from a donor egg and placed next to a skin cell. Both are zapped with a tiny electric shock, and if all goes well the egg grows into a genetic copy of the original animal.

The first two clones died. It took a couple of years, but three healthy clones were delivered to Charlo in the spring of 2003.

Soon after, Coleman received a reassuring message on his answering machine from John Matheson, a senior regulatory review scientist with the FDA's Center for Veterinary Medicine. "A decision on whether or how to regulate them is probably going to be into the early spring of '04," Matheson said.

That would be just in time for Coleman's clones to reach sexual maturity.

The spring breeding season passed without a decision. The first batches of semen stayed put in a freezer.

Now, the melting snow reminds him that spring is approaching again.

"The breeding season is coming upon us," he said, "and if you don't hit that, you got to wait a whole year."


Cattle ranchers have long embraced advanced reproductive technologies in their quest to efficiently produce higher-quality milk and beef.

In the 1960s, they began using frozen semen and artificial insemination. Then, they employed in vitro fertilization.

Such techniques allow prized animals to pass on their desirable genes — but they don't ensure those genes will make it to the next generation.

"When you breed animals, they only donate 50% of the DNA, and it's totally random," said Cindy Daley, a professor of animal science at Cal State Chico's College of Agriculture. "Cloning takes the guesswork out of it."

A squad of First Downs, fathering legions of desirable offspring, could raise the quality of the entire Limousin breed.

But as with any new technology, there are always unknowns.

Some scientists believe all cloned animals have subtle genetic defects that arise from their unnatural start to life. Dolly the sheep, for example, suffered from arthritis and died at an unexpectedly early age.

The Japanese have conducted the most thorough studies of cloned meat.

The scientists, from the Operation of Urgent Research for Utilization of Clone Technology, subjected meat from cloned cattle to a battery of tests.

They compared its chemical composition to samples of regular beef. They analyzed amino and fatty acids. They subjected pieces to simulated gastric and intestinal juices to measure digestibility. They fed the meat to rats for 14 weeks and tracked their motor activity, reflexes, grip strength and other characteristics. Then they killed the rats and conducted autopsies.

In a 2004 report, the researchers concluded that there were "no significant biological differences" between natural and cloned beef.

The U.S. FDA began studying the safety of food produced from cloned animals and their offspring in 2001. The agency commissioned a report from the National Academy of
Sciences, which found that clones present "a low level of food safety concern" based on the limited data available.

The FDA issued a draft summary of its risk assessment in 2003, concluding that cloned animals and their offspring posed no increased risk to food safety.

However, the FDA emphasized that it had "made no policy decision that these products may be sold" and asked ranchers to voluntarily keep clones and their offspring out of the food supply until a final decision was made.

FDA officials won't say when they expect that to happen or discuss other aspects of their deliberations.

The North American Limousin Foundation decided on its own to include clones in its breed registry only if their owners refrain from selling semen until the FDA signs off.

Everyone assumed it would be a short wait.

"We were pretty confident that science would prevail in a timely fashion," Andersen said.

Time is relative in a place like Charlo. Nestled in a flat valley in the shadow of the Rocky Mountains, it is a landscape where life often seems measured more by season than by clock.

Downtown Charlo is little more than a widening in Montana Highway 212. There is a post office, a fire department, a grocery store, a senior center, an Exxon station, Tiny's Tavern and the M Bar 7 Cafe.

Amber Doty, the cook, is a meat-eater in a community built on cattle. But the thought of cloned beef is just too futuristic for her.

"It's just not right to clone anything," she said.

Even if regulators declared the meat safe, she wouldn't eat it. "You never know how well science works," she said.

Barry Ambrose, who guides tourists on the Lewis and Clark Trail and prefers to eat elk he kills with his own bow, hasn't caught up to the idea either.

"I just don't like fooling around with nature," said Ambrose, son of the late historian Stephen E. Ambrose.

Such ambivalence in the heart of cattle country doesn't bode well for those anticipating a favorable FDA decision.

"The scientists and ranchers always want to say it's just about the science, but it's not," said Foreman of the Food Policy Institute. "We have all sorts of emotional attachments to our food. And to think that people are going to choose without this question coming up — it's just not right."

Most ranchers are simply exasperated. Out on the plains, where tens of millions of cows graze each year, a steak is a steak is a steak.

Ranchers and dairy farmers are losing patience with the moratorium.

Frank Regan spent $65,000 to clone his prized Holsteins Dellia and Deborah. Now, he has five clones producing nearly 500 pounds of milk each day at his family farm in Waukon, Iowa.

He can't sell the milk so he's diverting it to a tank to feed calves. All he can do is wait for the FDA.

"It's kind of like taking a girl out for about 10 years and then telling her you're never going to marry her," he said.

In August, Colby Collins of Frederick, Okla., will begin delivering the first of 50 calves sired by a clone of Full Flush, a popular Chianina bull from a nearby ranch.

Collins could have bought semen from the real Full Flush for $50 a straw. Instead, he paid just $20 for semen from one of the five Full Flush clones.

"When you can cut a dollar here and a dollar there, you've got to do it," he said.

The calves will be sold to youngsters, who will raise them for a year and enter them in county fairs and farm competitions, collectively known as the club calf circuit.

The circuit has come to occupy an odd spot in the clone conflict. Everyone knows the club calves will be sold for slaughter after their last turn in the show ring. But no one likes to dwell on it.

Don Coover, a vet and semen broker in Galesburg, Kan., has promised two clone offspring to kids to raise for the circuit. The FDA has no way to track them.

"They will go into the food chain, no question, in six or eight months," he said.

And that's just the beginning.

"I'm selling hundreds — maybe thousands — of units of semen from bulls that were cloned," he said. "They're going to be slaughtered, and the FDA can't do anything about it."

There is no way to distinguish calves fathered by clones from those fathered by the original bull. A DNA analysis would reveal only that they have different mothers.

"If this turns into a crime," Coover said, "it would truly be the perfect crime."





May 29, 2003

University of Idaho, Utah State University Team First to Successfully Clone Equine

      A University of Idaho-Utah State University research team is the first worldwide to clone a member of the horse family, a mule, according to an article to be published in the Journal of Science.

The research team includes Gordon Woods, UI professor of animal and veterinary science, Kenneth L. White, Utah State University professor of animal science, and Dirk Vanderwall, UI assistant professor of animal and veterinary science.

The baby mule, Idaho Gem, was born May 4. It is the first clone of a hybrid animal. A mule results from a cross between a female horse, a mare, and a male donkey, a jack. As hybrids, mules are sterile, except in extremely rare cases.

Veterinary examinations of the foal and its surrogate mother showed them to be in good health, Woods said. The foal romped with its surrogate mother during a news conference on the UI campus this morning to announce its birth.

The foal’s DNA comes from a fetal cell culture first established in 1998 at the University of Idaho.

As scientifically and commercially significant as their accomplishment is for the horse industry, Woods said he is most excited because the project provides a new animal model, the horse, to advance understanding of human cancer.

Woods believes the breakthrough understanding of cellular biology necessary for horse cloning to proceed may offer new insights into cancer development in humans.

Woods, UI professor of animal and veterinary science, began working on the cloning project in 1998. As director of the Northwest Equine Reproduction Laboratory on the UI Moscow campus, he has spent much of his career studying horse-breeding issues.

Horses present a large challenge to those who would use advanced technology to assist them. Only two “test-tube” horse foals, babies conceived in a test tube, have resulted from in vitro fertilization experiments worldwide.

The mule clone born in May is the full sibling of a champion racing mule owned by Idaho businessman, UI benefactor and mule enthusiast Don Jacklin of Post Falls.

For three years, from 1998 to 2000, the team worked without apparent success. After transferring the nuclei from the mule cells into 134 horse eggs and implanting them into mares, two apparently “false pregnancies” resulted, but both failed to proceed past four weeks.

In 2001, the team began to focus on the calcium levels in the fluid surrounding the eggs during the cloning procedure. The change led to the first fetal heart beat, signifying the team had crossed a significant hurdle in the experiment. That year, researchers transferred 84 eggs, establishing five apparent pregnancies.

“ The results were impressive and immediate,” Woods said. The first change led to a significant advance in the development of cloned embryos.

In 2002, Woods, White and Vanderwall continued to adjust the calcium levels in the fluid surrounding the egg during the cloning procedure. That change dramatically increased the team’s success.

The team established 14 pregnancies using mule DNA in 113 attempts. Eight of the pregnancies continued to at least the 40-day stage when heartbeats were detected.

To test whether mule DNA could be limiting success, the team also made 61 attempts to use horse DNA. The test resulted in seven apparent pregnancies, two of which developed heartbeats. Neither of the horse clone pregnancies developed past the critical 60-day threshold, however.

The UI-Utah State team is the first to succeed among several teams worldwide attempting to clone a member of the horse family. The 2002 preliminary testing showed the method developed by the researchers to successfully clone a mule should work equally as well with a horse, Woods said.

“It basically came down to a matter of numbers, and we wanted to focus most of our attention on cloning a mule, which was our original objective,” Vanderwall said.

White is widely recognized as an expert on cattle cloning and brought cloning expertise to the team. Vanderwall, who like Woods, earned doctor of veterinary medicine and Ph.D. degrees, brought extensive clinical expertise to the team.

Woods had taken an interest in basic horse physiology after becoming intrigued by the observation that stallions, male horses, do not develop prostate cancer.

The horse’s basic metabolism is “slow” compared to humans and many other mammals, Woods said. He speculated that difference in cellular activity might play a role in both cancer development and reproduction.

He formed an outside company, CancEr2, to investigate that observation with the backing of private investors. The studies showed a fundamental difference between men and stallions in the calcium concentrations within the cells and surrounding fluid.

Woods said the team will explore other lines of scientific inquiry opened by this year’s success.

Cloning Allows Scientists to Increase Impact of Genetic Traits


MOSCOW, Idaho – Cloning has occurred in nature for billions of years in plants and some lower animals. Cloning is asexually producing offspring that are genetically identical to a parent plant or animal. For example, a plant grown from a leaf cutting is a clone of the original plant because they are genetically identical.


In the laboratory, scientists use somatic cell nuclear transfer techniques to produce animals with genetic material identical to just one parent. At present, 10 species have been successfully cloned, among them cattle, pigs, sheep, mice and cats.

Using microsurgery techniques, scientists remove the nucleus from an egg cell, which contains the cell’s genetic material, creating an enucleated egg. The genetic material from a somatic cell – which can be any body cell other than an egg or sperm cell – is removed from the cell and injected into the enucleated egg. An electric pulse fuses the egg cell and new genetic material. The cell is then treated in media that allows it to develop into an embryo that can be implanted in a surrogate mother’s womb and carried to term.

Cloning will not replace sexual reproduction in animals, but allows scientists to increase the impact of important genetic traits in populations of animals and may be the only means of reproducing some animals. For example, cells from endangered animals may be used to increase populations of some species, but cloning them also requires surrogate mothers that are genetically similar to carry the embryos to term.



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