Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

The Clones On Our Plates


Is food from cloned animals safe to eat? The debate continues, but some of the meat and milk is already making its way into the marketplace in the U.S. - and possibly Canada.

by Alex Roslin
The Montreal Gazette
Saturday, September 06, 2008

Clones. To some, the word evokes Frankenfood or Star Wars Stormtroopers. To veterinarian Donald Coover, it conjures a miraculous world of super-cows with high milk and meat yields and horses as fast as Secretariat, the legendary Triple Crown-winning thoroughbred.
Coover is helping to lead the clone revolution out of tiny Galesburg, Kansas, a village of 150 with one convenience store and two churches, surrounded by fields of wheat and cattle ranches.
This is the home base of Coover's company SEK Genetics and its thriving business of selling semen from elite cows to farmers. He says he has also sold enough semen from cloned cows to inseminate tens of thousands of farm animals, and he says "dozens at least, hundreds probably" of other cloning businesses in the U.S. are doing the same thing.
Despite a request by the U.S. Department of Agriculture that farmers respect a voluntary moratorium on selling food from clones to consumers, Coover says he has sold dozens of clones and their offspring to farmers for use in food production since 2001.
"It's not illegal, and it's not unethical," he said. "Instead of having just another damn horse, you have Secretariat every time. That is why it's enormously useful." Cloning is a way to create a perfect genetic copy of an adult animal. Its cell material is transferred to an egg that is grown into an embryo and implanted in a surrogate mother.
Advocates like Coover say the process can help farmers duplicate top livestock and improve meat and milk yields.
"It's frustrating to me that we've been able to develop this incredible technology, and people are bitching and moaning about it," he said.
Food from clones is still banned in Canada, but Health Canada is now considering whether to lift the ban.
Surveys show widespread public unease about the technology. In a 2003 survey for the Canadian government, only 24 per cent of Canadians and 32 per cent of Americans supported the use of cloned animals for food.
The most common concern was "long-term risk to human health," cited by 37 per cent of Canadians.
After a seven-year scientific review, the U.S. Food and Drug Administration last January okayed meat and milk from cloned cows, pigs and goats and their offspring as being safe to eat.
The selling of clone food to consumers is still on hold while the U.S. Department of Agriculture works out a plan to assuage the concerns of consumers in the U.S. and abroad. In the interim, it has asked cloners and livestock farmers to continue to respect its voluntary moratorium.
"The food in every respect is indistinguishable from food from any other animal," FDA official Stephen Sundlof told reporters last January.
But the scientific debate about clone food still appears far from over. In fact, Sundlof's statement seems to be contradicted by a 2006 background paper on cloning prepared by the Canadian Food Inspection Agency that was obtained through an access-to-information request.
The CFIA paper and the FDA's own 968-page scientific review published last January depict cloning as an unpredictable technology fraught with problems that almost always leads to outright failure or disfigured animals that aren't safe to eat.
Even in cases where clones and their offspring look healthy, they appear to suffer from genetic abnormalities and research is sparse on whether their food is safe, the documents say.
"There is not enough data to indicate there will be no problem," said Pascale Chavatte-Palmer, one of the world's leading cloning researchers, whose studies are cited over 50 times in the FDA report.
"I think we should know more. We feel there is a rush to accept those clones," she said in an interview.
In Europe, food from clones isn't being sold because of formal and informal moratoriums in various countries. But this week, the European Parliament voted 622-to-32 to urge the European Union's executive branch to ban food from clones, citing concerns about food safety, consumer confidence and animal suffering.
The move followed a report from the European Food Safety Authority in July that said, while there is "no clear evidence" food from cloned cows and pigs is unsafe, more study is needed because of the lack of data.

***

Chavatte-Palmer is no anti-biotech Luddite. She's dined on what she calls "very good" cloned Kobe beef, which she thinks was most likely safe to eat. Yet, she paints a picture of a technology that's about as precise as a steamroller.
Out of 1,000 attempts, a clone embryo is successfully developed and implanted into a surrogate mother only about 100 times, said Chavatte-Palmer, who is a research leader at the French government's Institut Nationale de la Recherche Agronomique, the leading agricultural-research institute in Europe.
Of those 100 embryo transfers, just five fetuses are typically born alive, she said.
The rest mostly miscarry due to genetic or physical defects or abnormal placentas. Their most common abnormality is called large offspring syndrome, which results in fetuses 20- to 85-per-cent larger than average.
The animals that survive to birth also often have large offspring syndrome - which occurs in up to half of clone births - or other severe problems like a deformed head, contracted tendons, extreme diarrhea, diabetes, respiratory failure, heart disease and kidney problems. Many die shortly after birth.
A Japanese study cited in the FDA's review painted an unsettling picture of several clone calves that had died. "The neck was bent backwards, the hind legs were stretched tightly or the second joints were bent toward the opposite direction from the normal position," it said.
"Calf No. 12 was disemboweled at parturition and the face of calf 16 was warped."
Some of the calves had been born with "an 'adult' appearance" and displayed "many wrinkles in the skin, thick bone structure and rough hairs resembling those of adult males."
Indeed, Dolly the sheep, the first mammal cloned from an adult cell in 1996, lived for only six years, half the average lifespan for her breed, and developed obesity, lung cancer and premature arthritis.
Even the few clones that appear to be healthy really aren't, said Chavatte-Palmer, who is one of a small handful of scientists worldwide to have studied the long-term health of clones.
"Cloned animals, although apparently normal, are however significantly different from (conventionally raised animals) maintained in the same conditions," she wrote in a paper in the journal Animal last year.
The CFIA came to a similar conclusion in its paper. "There is an inadequate amount of information on any species to determine long-term physiological effects (of cloning)," it said.
"Early research suggests that these animals have subtle gene expression abnormalities."
The CFIA said cloning "could have long-term effects that compromise animal health and survival."

***

So is food from clones safe to eat? The FDA's review concluded that meat and milk from deformed clones, which die early in life or need to be euthanized, is unsafe.
But in a little-noticed passage deep in its report, the agency okayed this food for entry into the human food chain if it is treated in a meat-rendering plant.
Rendering plants process dead animals from zoos and shelters, old meat from grocery stores and butcher-shop trimmings by chopping them up, then cooking them at high temperatures.
Rendering leads to several products that enter the human food chain directly and indirectly, including lard, tallow, protein for livestock feed and crop fertilizer.
The FDA report cites no research on whether or not rendered food from abnormal clones is safe.
"There is not a single study of that," said Jaydee Hanson, a policy analyst at the Washington, D.C.-based Centre for Food Safety.
Hanson said it can't be assumed the rendering process makes all animal products safe to eat. "They don't let animals with mad cow disease enter the food supply through rendering," he said. "They have a belief this is safe. Belief is wonderful for a religious organization."
As for healthy-looking clones, the FDA says their food is identical to that from other animals. "These products are not different than food from traditionally bred animals," Bruce Knight, a senior U.S. Department of Agriculture official, told reporters last January.
But the CFIA paper and the FDA's own review raise questions about this conclusion as well.
"The use of (cloning) may have an effect on gene expression in the resulting animals and thus alter food characteristics, such as biochemical composition, which may be a food safety concern," the CFIA paper says.
"Stress-related developmental problems in young clones may also present an indirect food safety concern. This may lead to increased usage of antimicrobials for the treatment of such disease-prone clones and could also have an effect on the shedding of antimicrobial-resistant bacteria."
The FDA's review acknowledges no large-scale studies of the meat and milk of clones have been done. It relies on 10 small-scale studies involving an average of just five clones each.
Five of the 10 studies found statistically significant differences between food from clones and conventionally bred animals.
Chavatte-Palmer did one of those five studies. She found cow clones reached puberty an average of 62 days later than normal animals, which she said "probably will affect the quality (of their meat) ... The full maturation of muscle is delayed in clones."
As well, she found milk from cow clones had different levels of some fatty acids and enzymes than milk from conventional animals. She concluded more research is needed on whether the differences could cause food allergies.
For pork, the FDA cited only two studies involving seven clones in total, both done by biotech company ViaGen. They found the clones grew 30-per-cent slower than normal animals and had less meat. Two of the clones had so many health problems their data wasn't even included in the final results. The FDA questioned the study because of the small number of clones.
No studies have been done at all on food from goats, the third clone species that the FDA okayed.

***

For all the talk about clones, the fact is we're actually unlikely to ever see a clone T-bone at the butcher shop. That's because clones are up to 10 times more expensive to produce than conventional animals - $10,000 to $16,000 for a cow and $6,000 for a pig.
The main source of clone-derived food is likely to be naturally bred offspring of clones. The FDA says clone offspring have fewer health problems than clones and are identical to normal animals.
But the CFIA background paper says there is "limited" data on food from clone offspring and cited two major U.S. reviews of the issue that expressed concern about the "inconclusive evidence" about the safety of their food.
The FDA's report cited no studies on meat or milk from the offspring of cows or goats and only two studies on pork from the offspring of pig clones. The clone offspring were mostly the same as conventional animals, but like the clones had several differences: Of 58 nutrients tested, clone offspring meat had significantly less of seven nutrients, while more of two others. It was also somewhat fattier, more acidic and shrunk more during cooking - indications of poorer quality.
There is also little longer-term research about the health of offspring as they age.
The FDA review says the offspring seem to be healthier than their clone parents because their genetic errors are "reset."
But one of the scientists the FDA cites in its review says he disagrees with the agency's conclusion.
Dean Betts, an associate professor of biomedical sciences at the University of Guelph, is one of the few scientists to have looked into the health of clone offspring.
Betts found the offspring of goat and sheep clones have genetic abnormalities - significantly shorter telomeres, which are the chromosome endings that are believed to control aging and susceptibility to cancer.
Shorter telomere lengths could explain why many clones seem to age faster than normal animals. Dolly the sheep was also found to have shorter telomeres.
"We don't know what it means or if it has health impacts," Betts said. "I would say not enough study has been done ... There could be some impacts on the species itself over generations."
In France, Chavatte-Palmer had hopes of getting some definitive answers to the questions about the health and food of clones and their offspring. But her cloning work has ground virtually to a halt. Funding has dried up, she says, because cloning is a sensitive issue for grant-funding agencies.
"We have piles of data that we haven't had time and money to get help to analyze," she said. "It's very difficult to get funding in this area of research. It's frustrating, very frustrating."

SIDEBAR
Are we already dining on clones?
No labels on clone food in U.S., FDA says

Canadians may have been consuming food from clones for years without knowing it, despite a Health Canada ban.

That’s one of the surprising revelations from documents on cloning from the Canadian Food Inspection Agency obtained under the access-to-information legislation.

About 800 cloned dairy cattle produced through an early version of cloning called embryonic-cell nuclear transfer and from embryo splitting have been registered in Canada since the 1980s, said a CFIA background paper on cloning written in 2006.

The CFIA paper said food from these clones can be sold to Canadian consumers. “There is generally no restriction on the marketing of products, by-products or the progeny of animal clones that are produced using the embryo-splitting technique in Canada or elsewhere,” it said.

The CFIA paper didn’t say whether milk from the cloned cows was indeed sold to consumers. An agency spokesperson didn’t respond to a request for comment.

Health Canada, however, says no food from clones, including embryonic-cell nuclear-transfer clones, can be sold in the country. “It shouldn’t be on the market,” said Paul Duchesne, a department spokesman.

Embryonic-cell nuclear-transfer was used in the 1980s and early 1990s but was replaced in the mid-1990s by an improved technique called somatic-cell nuclear-transfer cloning, which replicates an adult animal, instead of an embryo.

Donald Coover, a Kansas veterinarian who says he has sold clones and their semen to farmers in the U.S. for years, said hundreds of embryonic-cell nuclear-transfer clones were produced in the U.S. and that their meat and milk quietly entered the U.S. food supply without any official safety review.

He said it’s very likely the same thing happened in Canada. “Nobody at the time made a big deal about it.”

And now that the U.S. Food and Drug Administration has okayed clone food for human consumption, the CFIA again seems to have no plan for keeping it out of the country, according to an internal email sent by a manager at the agency.

“CFIA has no specific regulatory controls for animal clones,” said the email, dated Feb. 14, a month after the FDA’s decision last January. “There are no special tracking provisions.”

The issue of tracking food from clones is complicated by the fact that the FDA has decided not to label the food, and there’s no way to test if a particular animal is a clone.

“All we’ve had are some preliminary discussions on… the feasibility of detection,” said a CFIA official, who spoke off the record because she is not authorized to talk with journalists. “Nothing has been put in place, and no policies have been created around that.”


SIDEBAR
Quebec farmers shrug off cloning—it’s too costly

Quebec farmers don’t seem to be rushing to embrace cloning. The Union des Producteurs Agricoles, representing 44,000 Quebec farmers, says it has no position on whether to embrace food from clones.

“We haven’t discussed it very much,” said spokesman Patrice Juneau. “It’s not a very important issue for us.”

The 3,800-member Fédération des producteurs de porcs du Québec, also has no position, said spokeswoman Nathalie Hansen.

“The steps required to produce a live (clone) animal are almost a nightmare for farm applications,” said Roger Sauvé, a cow veterinarian in St. Louis de Gonzague, 45 kilometres southwest of Montreal, who specializes in reproductive services for farmers.

“It’s very, very expensive to produce cloned animals right now. Farmers are not ready to pay that kind of money. Practically, it doesn’t make sense.”

Sauvé said existing reproductive technologies are more efficient and cheaper and also offer the advantage of improving a herd’s genetics if two top animals are bred together, while clones can only be as good as their progenitors.


For more information:
- European Parliament reports on cloning
- The Center for Food Safety’s report on food from clones


Clone, Clone On the Range












French researcher Pascale Chavatte-Palmer (above) says there is a rush to accept cloned farm animals and not enough funding available for necessary research.

By Alex Roslin
February 21, 2008

The Georgia Straight
[read the original story]

Since many cloned farm animals are born with abnormalities, how safe is their meat and milk?


When the U.S. Food and Drug Administration announced in January that food from cloned farm animals was safe to eat, the agency said the science was clear. Officials said meat and milk from cloned cows, pigs, and goats are exactly the same as conventional food.
“The food in every respect is indistinguishable from food from any other animal so it is beyond our imagination to even find a theory that would cause the food to be unsafe,” Stephen Sundlof, director of the FDA’s Center for Food Safety and Applied Nutrition, told reporters at a news conference in Washington,D.C.
In her office outside Paris, one of the world’s leading cloning researchers, Pascale Chavatte-Palmer, didn’t think the research was clear at all. Working out of the French government’s National Institute for Agricultural Research, she helps supervise one of only two or three noncorporate research facilities worldwide studying the long-term health of—and food products from—large numbers of cloned animals.
Chavatte-Palmer, a group research leader at the INRA, has found milk and meat from cloned cows are, indeed, different. “The full maturation of muscle is delayed in clones,” she said over the phone from her office 25 kilometres southwest of Paris. “This probably will affect the quality [of the meat]. It will certainly be a bit different.”
And those aren’t the only differences she’s found between clones and normal animals. In a series of papers she has coauthored in leading scientific journals, Chavatte-Palmer has reported that clones of cows reached puberty 62 days later, on average, than normal animals and they were 56 kilograms heavier when they did so. And then there were the huge numbers of clones that didn’t make it that far.
At an INRA farm whose exact location Chavatte-Palmer can’t disclose for security reasons, she has helped produce some of the world’s most comprehensive research on what happens when we try to clone farm animals. Her studies are cited 54 times in the FDA’s mammoth 968-page risk assessment on food from clones.
The idea of cloning is to create a perfect genetic copy of an adult animal by taking the nucleus from one of its cells and transferring it into an egg that has no nucleus. In about 100 of 1,000 cases, the egg develops into an embryo that can then be implanted in a surrogate mother.
Of those 100 embryo transfers, the INRA research found more than 50 fetuses spontaneously abort in the first trimester of pregnancy because of genetic or physical anomalies or defects in the placenta—a rate two times higher than for conventionally bred cows.
Another 20 or so abort later in pregnancy, most often because of a grotesque ailment sometimes called large offspring syndrome, which results in a fetus 20 to 85 percent larger than average.
In the end, fewer than five of the fetuses, on average, are born alive, Chavatte-Palmer reported in a 2004 paper in the journal Cloning and Stem Cells. This finding is in line with a European Food Safety Authority draft scientific opinion on cloning released in December 2007 that said the success rate for clone fetuses reaching term is 0.5 percent to five percent.
The FDA risk assessment offers a similarly glum, if a tad less dismal, cloning success rate of five percent to 18 percent.
But making it into the world alive is just the beginning of the struggle for many clones. Many are born with limb and head deformities, contracted tendons, extreme diarrhea, diabetes, respiratory failure, heart disease, and kidney problems.
Contrary to the sunny views of FDA officials at the Washington news conference, the agency’s risk assessment makes for sombre reading about the unpredictable science of cloning. It cites one 2000 Japanese study that painted an especially unsettling picture: “Calves [numbered] 11, 13-15, 20 and 22 died at parturition [birth] or several days later and had significant morphological abnormalities of the kidney or cacomelia [limb deformity]; the neck was bent backwards, the hind legs were stretched tightly or the second joints were bent toward the opposite direction from the normal position…
“Calf number 12 was disemboweled at parturition and the face of calf 16 was warped and the second joints of both hind legs were bent in the opposite direction from the normal position.”
This study, published in the Journal of Reproduction and Fertility, also reported on the bizarre appearance of many clone calves at birth, which “had an ‘adult’ appearance” and displayed “many wrinkles in the skin, thick bone structure, and rough hairs resembling those of adult males”.
Some of these postnatal complications are, again, caused by large offspring syndrome, which occurs in 14 percent to 50 percent of successful clone births, compared to 9.5 percent of animals produced by in vitro fertilization.
As for older clones, virtually no research on their health and longevity has been done, even though it’s been 12 years since Dolly the sheep—the first mammal cloned from an adult cell—was born in 1996. Dolly herself had to be euthanized at the young age of six after developing arthritis and lung disease.
The FDA is quite frank about most of these problems in its risk assessment. “Many questions have been raised regarding the immune function of clones and their ability to resist or recover from disease, yet few studies have examined this issue directly in bovine clones,” it says.
So how can the FDA still okay food from clones? The reasoning goes like this: yes, almost all cloning attempts fail, and, yes, there is evidence the animals that do survive are genetically abnormal. But the FDA says it hasn’t been shown that such genetic abnormalities make food from clones unsafe. “The relevance of ‘epigenetic normality’ to food consumption risks is unclear,” its report notes.
So the FDA concludes that as long as clones are pronounced to be physically healthy by a food inspector, their meat and milk are safe to eat.
The logic baffles Jaydee Hanson, a policy analyst at the Washington, D.C.–based Center for Food Safety. “They have no data. The standard way to assess something like this is to do long-term studies of feeding it [cloned-animal products] to animals,” he said, speaking on the phone from his office.
“The [FDA’s] basic assumption is if an animal can walk in the door of a slaughterhouse, it’s safe to eat. I don’t know what slaughterhouses they visited. There are tremendous problems in slaughterhouses about whether we’re packaging meat we shouldn’t.”
But beyond that, it’s still an open question whether or not any clones are really healthy. The FDA acknowledges as much. Its report cites a 2004 paper in the New England Journal of Medicine by cloning pioneer Rudolf Jaenisch, the MIT biologist who created the first genetically engineered animals in the 1970s.
He wrote: “Gene-expression analyses indicate that four to five percent of the overall genome and 30 to 50 percent of imprinted genes are not correctly expressed in tissues of newborn cloned mice. These data represent strong molecular evidence that cloned animals, even if they survive to birth, have serious gene-expression abnormalities.”
In France, Chavatte-Palmer concluded in a paper last year in the journal Animal: “Cloned animals, although apparently normal, are however significantly different from contemporary controls maintained in the same conditions.”

It also turns out there’s no solid evidence for saying the meat and milk of clones really are the same as those from conventionally bred animals. No large-scale studies have been done. “Information on the composition of meat or milk from animal clones has been limited,” the FDA’s report says.
The agency explored the idea of sending some clone food for lab tests but dropped the plan because, apparently, it didn’t have access to enough sample material for a statistically valid result.
Instead, the FDA relied on several small-scale studies of meat and milk composition involving an average of five clones each. Five of the 10 studies found differences between food from clones and conventionally bred animals.
One study coauthored by Chavatte-Palmer last year in the journal Theriogenology reported statistically significant differences in vital fatty acids and enzymes in milk from clones compared to conventional animals.
Of five studies of cow meat, two—including Chavatte-Palmer’s Theriogenology paper—found significant differences in fat content, proteins, fatty acids, and enzymes between beef from clones and that from conventionally bred cows. For pork, only two studies were cited involving five clones in total, both from biotech company ViaGen. They found the clones had less back-fat thickness and meat yield than control animals, plus their meat was darker and redder.
No studies have been done at all on food from goats, the third clone species that the FDA okayed for food production.
Apart from these 10 studies, the FDA cited three others that also showed differences in clone meat or milk, but the reason may have been the varying diet of the animals.
These less-than-stellar results went unmentioned when U.S. officials spoke to reporters in January about the decision to okay clone food. “These products are not different than food from traditionally bred animals,” said Bruce Knight, the agriculture department’s undersecretary for marketing and regulatory programs, at the news conference. He described cloning as just “another breeding technique” that “has now been demonstrated to be safe”.
Chavatte-Palmer thinks more study is still needed. She’s no anti-biotech advocate, and she personally believes that meat and milk from clones are probably safe to eat. But she added: “I think we should know more. Our study is one of the biggest published, but it’s still limited. There is not enough data to indicate there will be no problem. We feel there is a rush to accept those clones.”

Food from cloned animals could officially enter the U.S. food supply starting as soon as a few months. The short delay is because of a temporary voluntary moratorium suggested to the industry by the U.S. Department of Agriculture—time to work out a plan to assuage the concerns of consumers in the U.S. and abroad.
The moratorium would be extended at least another year by a farm bill that the U.S. Senate passed in December requiring an outside study by the National Academy of Sciences of the safety of food from clones and impacts on human health. That bill is now the subject of negotiations with the House to reconcile different versions.
If the moratorium is lifted, clone food seems likely to slip largely unnoticed into American grocery stores without much possibility of being tracked. That’s thanks in part to the FDA’s decision not to require labels on the food or any tracking mechanism for cloned animals and their offspring.
There’s also a practical reason the food will be virtually impossible to track: there’s no way to test whether an animal is cloned or had a clone ancestor. “The answer is no,” said the FDA’s Sundlof when a reporter at the January news conference asked if such a test is possible. “These animals are indistinguishable; both the animal and any food produced from those animals is absolutely indistinguishable from any other food source.”
And despite the voluntary moratorium, food from clones has already been entering the U.S. marketplace for about 20 years, according to Donald Coover, a Galesburg, Kansas, veterinarian and owner of SEK Genetics, which retails cow semen to farmers. Coover said he himself has sold U.S. ranchers several dozen clone offspring as well as “thousands of units of semen” from clones. He put the number of other U.S. cloning businesses flouting the ban at “dozens at least, hundreds probably”.
“It’s not illegal and it’s not unethical,” said Coover, reached on his cellphone at the Iowa Beef Expo. “Instead of having just another damn horse, you have Secretariat every time. That is why it’s enormously useful.”
Coover said food from clones first entered American diets in the 1980s and early 1990s from an initial generation of clones made with split embryos. This was long before Dolly, who was cloned from an adult cell. The earlier clones didn’t catch on with ranchers because it was a crapshoot trying to predict if an embryo would turn into a superior animal as an adult.
Nonetheless, Coover said hundreds of split-embryo clones were produced, and their meat and milk quietly entered the U.S. food supply without any formal assessment of the products’ safety. “I’m not aware of any large-scale studies,” said Coover. “It just was not considered as a health or nutrition issue by the FDA.”
FDA spokesperson Brad Swezey refused comment, saying in an e-mail: “We aren’t doing interviews on cloning.”
Coover said it’s very possible some offspring of split-embryo clones also entered Canada’s food supply. “I would be stunned [if that wasn’t the case]. I can tell you for certain there was nobody up there looking at this.”
In Canada, food from both adult and split-embryo clones is banned by order of Health Canada. The Canadian Food Inspection Agency, which enforces the ban and monitors food imports, didn’t respond to a request for comment on Coover’s claim or how it plans to stop clones from entering the country.
Health Canada is now studying the FDA risk assessment as part of a reevaluation of the Canadian policy on food from clones.

For all the attention on food from clones, the fact is you’ll never see a clone T-bone at your butcher. That’s because clones are up to 10 times more expensive to produce than conventional animals—$10,000 to $16,000 for a cow and $6,000 for a pig. Instead, most clone food in our diets would not come directly from clones themselves.
Remember all those abnormal clones that are euthanized or die prematurely? You didn’t think they’d go to waste, did you? The FDA says their meat is unsafe to eat. However, its risk assessment says an acceptable disposal method would be to send the carcasses to rendering plants, where they would get chopped up and cooked with spoiled meat from grocery stores, dead animals from zoos and shelters and butcher-shop trimmings, then turned into pet food and human food products like lard.
The FDA cites no research on whether or not rendered food from abnormal clones is safe. “There is not a single study of that,” says Jaydee Hanson, of the Center for Food Safety. “They don’t let animals with mad-cow disease enter the food supply through rendering.”
The other big source of clone-
derived food would be the naturally bred offspring of clones. “Everything in those tissues is the same as what you’re seeing with our natural conceived animals,” Bernadette Dunham, director of the FDA Center for Veterinary Medicine, told reporters in January.
But again, the FDA acknowledges in its assessment that the science is limited on the health of clone offspring or the composition of their meat and milk. The FDA risk assessment cites only two studies on pork from the offspring of pig clones—one of them from biotech company ViaGen. They found the clone offspring had less fatty acids, shorter back and loin lengths, and less bacon yield. No studies at all were cited on beef or milk from the offspring of clones. A few studies have found clone progeny tend to be born with fewer abnormalities than their parents, but there is little longer-term research on offspring as they age.
Nonetheless, the FDA concludes that any genetic errors in clones are likely “reset” in their offspring. Because of the lack of research on offspring of livestock clones, the agency cites evidence from the so-called mouse model: research on mice that suggests offspring of clones benefit from some kind of genetic reset button.
“We don’t have enough data to say that is 100-percent true,” Chavatte-Palmer said. “The mouse model has been shown not to be a good model for humans. I don’t see why it would be a good model for cows. The best model for cows would be cows.”
One of the few scientists who has looked into the health of clone offspring is Dean Betts, an associate professor of biomedical sciences at the University of Guelph in Ontario. Betts coauthored a pair of studies in the journal Molecular Reproduction and Development in 2005 and 2007 that found sheep and goat clones and their offspring have significantly shorter telomeres, the chromosome endings believed to control aging and susceptibility to cancer.
“It [the telomere] provides chromosomal stability. Without it, you have a greater chance of genomic instability, which leads to cancer,” Betts said in an interview from his office at the university.
Shorter telomere lengths could explain why many clones seem to age faster than normal animals. Dolly the sheep, for one, was found to have shorter telomeres. “Do they [the offspring of clones] have a possibility of shorter life spans and age-related diseases?” Betts asked. “We don’t know what it means or if it has health impacts. I would say not enough study has been done…There could be some impacts on the species itself over generations.”
Asked if he agrees with the FDA’s assertion that genetic errors are probably reset in the offspring of clones, Betts said: “Based on my study, I wouldn’t support that statement. My study would say the opposite, that they are not reset.”
Back in France, Chavatte-Palmer had high hopes she could get some answers about the health, longevity, and food of clones and their offspring. But her cloning work has ground virtually to a halt. She said grant-funding agencies have turned down most of INRA’s proposals to study the facility’s 70 clones and offspring—one of only two or three such large groups of animals at a noncorporate facility anywhere in the world.
Now money has run out to maintain a group of normal animals in similar conditions as the clones—necessary in order to have a good comparison sample, Chavatte-Palmer said.
“We have piles of data that we haven’t had time and money to get help to analyze…It’s very difficult to get funding in this area of research. Europe doesn’t want to hear about it, even though we are told it [clone food] is safe. It’s frustrating, very frustrating. I’m thinking at some point it’s best to move on to something else.”