ViaGen Preserving and Multiplying Superior Genetics

WASHINGTON, D.C. (July 24, 2008) – The European Food Safety Authority (EFSA) announced today its final scientific opinion that food from cloned cattle and pigs is safe, and there are no implications of animal cloning on the environment. Key findings of the EFSA Scientific Committee are:

There is no indication that differences exist in terms of food safety for meat and milk of clones and their progeny compared with those from conventionally bred animals.

Somatic cell nuclear transfer, or SCNT (the most common technique used to clone animals) results in the production of healthy cattle and pig clones, and healthy offspring that are similar to their conventional counterparts based on parameters such as physiological characteristics, demeanor and clinical status.

From the data collected, no environmental impact is foreseen.

Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO) issued the following statement in response to the scientific opinion released today by EFSA:

“BIO supports the key safety findings of EFSA’s scientific opinion, which concludes that meat and milk from livestock clones and their offspring are safe, and are no different than foods from livestock produced through conventional breeding. EFSA’s findings are consistent with the U.S. Food and Drug Administration’s (FDA) January 2008 risk assessment on animal cloning, and the worldwide scientific consensus that livestock cloning is safe.

“Consumers benefit from cloning technology because the offspring of clones will produce better meat and milk products. This decision affirms the global scientific agreement that foods from livestock clones and their offspring are completely safe to eat.

“Cloning is a breeding technology that helps farmers and ranchers produce healthier animals. Animal clones are an exact genetic copy of an existing animal, a ‘twin’ born at a different time. The offspring of cloned animals are produced through conventional breeding, and their lineage gives them enhanced genetic traits.

“The primary goal of farmers and ranchers is production of healthy animals and this technology, like many others, advances that goal. As noted by EFSA and the FDA, there are no unique animal health risks associated with livestock cloning, as compared with other assisted reproductive technologies. In fact, cloning offers the potential to significantly improve health and well-being of the herd because cloned animals will be used to breed healthier offspring.

“Now is the time to invest in this and other science-based solutions to achieve an improved, sustainable and reliable food supply. Cloning is just one example of how agricultural biotechnology can provide those solutions to consumers, farmers and food processors and retailers around the world.”

In February 2007, the European Food Safety Authority (EFSA) was asked by the European Commission to provide a scientific opinion on the food safety, animal health, animal welfare and environmental implications of animal clones, obtained through the SCNT technique, of their progeny and of the products obtained from those animals. The final opinion also follows public consultation on a draft opinion issued earlier this year. The final opinion is posted online at: www.efsa.europa.eu.

For more information on cloning, visit www.clonesafety.org.

About BIO

BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

Personally, I blame the Industrial Revolution. If the average British housewife had never been separated from her agrarian roots, we would not be in half the mess we are in. We’d grow our own organic vegetables, make low-fat casseroles out of pigs’ entrails and live healthily and hysteria-free beyond the subliminal control of the Tesco mother ship. We might also be a teensy bit bored, but that’s another column altogether.

Can there be anything more depressing than the oppressive superstition of today’s food shoppers – predominantly female – when faced with what they perceive as “bad food”? I doubt it. Logic doesn’t get a look in. Although faced with galloping bills, a grave world food shortage and unassailable evidence that the high-salt, high-fat and high-sugar processed diet that they favour is killing their loved ones with kindness, consumers are opposed to technological solutions.

For – surprise, surprise – the first credible survey into attitudes to food derived from cloned animals has revealed strong concerns. The public – for which read women – are worried about safety, ethics and animal welfare. The Foods Standards Agency found that they regarded cloned animal products as “interfering with mother nature”; “an unstoppable juggernaut”; and “a slippery slope” – and that they plainly preferred to die of stale clichés rather than drink fresh milk from cloned cows. They feared such products might be unsafe for human consumption and wanted extensive five to ten-year tests – presumably until the moon was in Aries and Gemini was in the ascendancy – in line with checks on new medicines.

It is a funny old world. As food riots break out in Haiti and Egypt and leaders at the UN food summit declare that a relaunch of agriculture is necessary to feed the planet, the great British shopper takes anti- science to new levels by objecting to increased food production.

We have been here before. This same emotional argument put a stop to the widespread use of genetically modified cereals in the UK. GM became a tainted brand that is now snuck into cheap food in small print. Yet if there is evidence that GM foods do any environmental or human damage, I’m still waiting to see it. (like I’m still waiting for the predicted millions to die of human form CJD from infected burgers.)

The ironies mount up: the same people who happily pay thousands of pounds for IVF babies, or seek gene therapy cures for their child’s asthma, condemn genetic modification as “dangerous”. The fastidious public, misshapen by obesity and sentenced to early death by doughnut, worry about “Frankenstein food”.

What this irrationality illustrates, vividly, is how ignorant people have become since they were divorced from the basics of agriculture. The land taught a wisdom we have lost. Genetic modification is simply selective breeding; it has been key to farming since the first hunter gatherer decided to stay put and find a bull for his cow. The slow-motion process of modifying animals by breeding has been going on for thousands of years and there is not a single strain of cow, sheep, pig, horse, dog, cat or hamster that is not the result of extensive generations of species manipulation by humans. An identical process went on with plants. And by doing so, productivity has improved immeasurably.

It is completely bonkers to think that today’s animals and plants bear any resemblance to what used to exist in the wild. Once upon a time all dogs looked the same; we simply modified them by breeding those with genetic abnormalities. And clever gardeners have done the same: creating, for example, broccoli, cabbage and cauliflower as mutations from the same species of plant.

Genome selection means nothing more radical than clever breeding – discovering what kind of genes work best and using them to improve existing strains or exclude disease. Cloning is a further acceleration of that process – jumping the time period that normal reproduction takes; speeding up of the selection of the most productive. Scientists tasked with solving the world’s food crisis – and we can’t leave it to politicians – know it’s safe. Similarly, the US Food and Drug Administration has decreed produce from clones and their offspring “as safe as food we eat every day”. The European Food Safety Authority, a little more cautiously – because it works on European snail time – says the same.

What happened with GM cereals cannot be allowed to happen again over meat and milk simply because the British shopper is overwhelmed by the “yuck” factor. There is a much more at stake than the sensibilities of the squeamish. It is as simple as this: the welfare, productivity, health and sustainability of farm animals have to improve if the world is going to keep eating meat. The oceans are being fished out, agricultural land is going to biofuels: something has to produce the protein to keep the world alive. The first cloned Holstein dairy cows, said to be capable of producing 30 per cent more milk, have been born in Britain. Instead of getting the vapours, we should rejoice.

April 29, 2008

The world’s first cloned horse, Prometea, has had a foal.

Pegaso, her son, is the first offspring of an equine clone confirms, once again, that cloned animals can grow and reproduce normally, giving rise to healthy offspring.

Prometea with her foal Pegaso: The development may help the breeding of champion racehorses

The name Prometea, a Haflinger mare, is a reference to Prometeo (Prometheus), who was punished for stealing fire from Olympus for the benefit of mankind.

She entered the history books in 2003 when she was unveiled as the world’s first horse clone, one that offered a way to preserve the genetic heritage of many exceptional horses whose genes are presently lost because champion geldings are castrated.

“During these five years Prometea has been in very good health and often at the centre of media attention,” says her creator, Prof Cesare Galli of the Laboratory of Reproductive Technologies in Cremona.

“The ultimate proof of her normality has just come with the birth of Pegaso, on March the 17th 2008, after a single insemination with the semen of the Haflinger stallion Abendfurst.”

Pegaso has special significance in racing because sporting horses are castrated at a young age. “When they become adult and demonstrate to be champion horses, they are unable to reproduce and it is therefore impossible to obtain the next generation: the champion’s offspring,” says Prof Galli.

“This is a bitter reality that clashes with the driving principle of animal breeding and selection that is based on the reproduction of superior individuals to pursue genetic improvement of the breed.

“Therefore, today, horse cloning is simply an assisted reproduction technique that allows us to obtain copies/clones of castrated champion horses and finally, from these clones, the champion’s offspring that otherwise would never be born.”

Prof Galli showed the technology could revolutionise blood stock breeding when he unveiled a cloned foal of Pieraz, an Arab endurance champion, in 2005.

He has cloned cattle and pigs too, and worked with human embryo cells, which led to him being excommunicated by the Catholic Church, even though he did not himself destroy embryos but used embryonic stem cells that had been derived in other countries.

Prof Galli first encountered problems with the authorities when he unveiled Galileo, Italy’s first cloned bull, which was confiscated by Italy’s Health Ministry.

FOR IMMEDIATE RELEASE

January 15, 2008

Statement from Mark Walton, ViaGen President on FDA Final Risk Assessment on Food from Cloned Animals

Austin, TX -“ViaGen applauds the release of the U.S. Food and Drug Administration’s (FDA) rigorous scientific analysis of the safety of food from cloned animals and their offspring.

FDA’s determination that meat and milk from animal clones is safe to eat concludes the most extensive food safety review in FDA’s history, and complements two earlier reports from the National Academy of Sciences that reached the same conclusion.

“Cloning companies will continue to work out an orderly marketing transition with the food industry and relevant government agencies – including FDA and USDA – as we move toward commercialization.

“The number of cloned animals in the barnyard today is miniscule compared to the size of the total livestock population. In addition, clones are to be used as breeding animals, not for consumption. Because of a supply chain management system that allows tracking of cloned livestock, consumers are unlikely to ever eat these animals.”

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Responding to concerns in the food industry, companies developing cloned livestock have come up with a system to track the animals as they move through farms and slaughterhouses.

The system, which will be announced Wednesday, would make it easier for food companies or retailers to support claims that their products contain no meat or milk from cloned animals.

The program comes as the Food and Drug Administration is thought to be preparing to lift a voluntary moratorium that has kept milk and meat from cloned cows, pigs and goats out of the food supply.

The agency issued a draft report last year declaring that the milk and meat from cloned animals and their conventionally bred offspring were safe to eat. Agency officials said then that they would make a final decision after analyzing public comments, possibly by the end of 2007.

Some lawmakers, however, are trying to introduce legislation that would either force or urge the F.D.A. to delay its action until more study is done. The Senate version of the farm bill contains an amendment to that effect introduced by Barbara A. Mikulski, Democrat of Maryland, and Arlen Specter, Republican of Pennsylvania.

The meat and dairy industries have expressed concerns that consumers might shun food from cloned animals, despite the F.D.A.’s assurances. Some public opinion surveys have found that many people are morally opposed to cloned animals, not just concerned about safety. So some food companies and retailers have been interested in a way to show that their food is free of products from clones.

The tracking system is being announced by ViaGen and Trans Ova Genetics, two companies that account for most cloned livestock. The companies said they developed the plan over a 10-month period in consultation with the food industry.

Under the system, the companies would give each cloned animal an electronic ear tag with an identification number, which would be entered into a registry.

Farmers and breeders who buy the clones would be asked to put up a hefty cash deposit in addition to what they pay for the animal. The farmers and breeders would also commit to marketing the milk or meat only to those who want it. The farmers would be able to get their deposit back by proving that the animal either died or was sold to a meat packer or processor that accepts clones, with a signed statement from the packer or processor.

Leah Wilkinson, director for policy and industry relations for ViaGen, said that since cloned animals were expensive to produce, they would mostly be used for breeding other animals, not to make meat or milk.

”What we’re doing is allowing for those small number of animals to be segregated out from the food supply,” she said.

But Joseph Mendelson, legal director of the Center for Food Safety, an advocacy group, said the system gave consumers ”phony assurances.” He said animals would slip through because the system was voluntary and did not cover the progeny of cloned animals.

The Grocery Manufacturers Association, which represents major food companies, said in a statement released by the cloning companies that ”a rigorous clone segregation program is needed if this breeding technology is introduced.”

The group said the program ”addresses this need from a supply chain management standpoint,” but it added that, ”ultimately, consumer preferences will determine if meat, milk and other byproducts from cloned animals will be used in food products.”