Food from clones safe - EFSA (12/1/2008)

1.Food From Clones Safe, E.U. Draft Says
2.Dolly's long goodbye

NOTE: If anyone thought the EFSA could not possibly do anything to further discredit itself, then its latest approval based on scant evidence may confound them.

EXTRACT: All clones are defective, in one way or another, with multiple flaws embedded in their genomes. Rudolf Jaenisch, a geneticist at the Massachusetts Institute of Technology, estimates that something like 4-5% of the genes in a cloned animal's genome are expressed incorrectly. These often subtle genetic defects can have tangible consequences. (ITEM 2)


1.Food From Clones Safe, E.U. Draft Says
Similar Conclusion Expected From FDA
By Rick Weiss Washington Post Staff Writer Washington Post, January 12 2008

The European Food Safety Authority yesterday declared that meat and milk from healthy cloned cattle and pigs is 'very unlikely' to pose risks to consumers, opening the door to possible European sales of those controversial foods in the future.

The highly anticipated draft scientific opinion of the European agency comes just days before the U.S. Food and Drug Administration is due to release its final report on food from clones, which is expected to reach virtually the same conclusion. Some backers of the fledgling agricultural cloning industry have said they hoped that a positive report from Europe might help ease the process of gaining acceptance by American consumers.

It remains unclear, however, whether the European Union will ultimately approve the sale of cloned products, and if so, under what conditions.

Unlike in the United States, such decisions in Europe must incorporate social and ethical factors. And the European public broadly supports the 'precautionary principle,' which calls for society to err on the side of caution when risks are uncertain.

Moreover, the European agency, which provides scientific advice to the European Commission, noted in its report that many cloned farm animals have health problems, including life-threatening physiological abnormalities. In Europe, where animal welfare is a much higher-profile issue than it is in the United States, that reality could also become a stumbling block.

The 47-page report concluded, however, that unhealthy clones would be screened out by standard food inspection methods. And, echoing earlier assertions by the FDA, it found that milk and meat from healthy clones are as nutritious and safe as milk and meat from ordinary animals.

'Based on current knowledge there is no expectation that clones or their progeny would introduce any new food safety risks compared with conventionally bred animals,' the report said.

The report also concluded that sexually produced offspring of clones -- far more likely to enter the food supply than clones themselves, which are too valuable to slaughter -- are fully normal.

Scientists at a handful of companies around the world, including at least two in the United States, want to clone prize-winning beef cattle, dairy cows and pigs as a way to bring more consistently high-quality products to market. But consumer reaction has been chilly.

Some fear that clones may harbor hidden health risks, while others decry the high death rates seen in newborn clones and the suffering of their surrogate mothers, which can have trouble giving birth to their often oversize offspring.

Despite that wariness, and despite European agriculture's general lack of interest in adopting the technology, the EU has been under international pressure to rule on the products' safety -- in part so other nations can export their meat and milk products there without worrying about trade challenges.

The issue is also of interest in Europe because farmers there use semen from American cattle.

New Zealand has released a positive report on the safety of food from clones and their progeny, and Canada and Argentina are expected to follow soon.

The 'draft risk assessment' released by the FDA in December 2006 found no unique health risks from meat or milk from clones or their offspring. The agency has been reworking that analysis, taking into account new science and the more than 30,500 public comments it received. It is expected to release its final report any day.

Last February, noting progress made by the FDA, the European Commission asked its Food Safety Authority also to provide a 'scientific opinion' on the safety of foods from clones and an assessment of cloning's effects on animal health and welfare and on the environment.

Yesterday's report was a first draft of that opinion and will be open for public comment for 45 days. It asserted that the introduction of cloned animals into agriculture will not affect the environment.

'Cloning does not involve changes in DNA sequences and thus no new genes would be introduced into the environment,' it said.

The report noted that a different European advisory group is preparing a study of the ethical implications of bringing cloning to European agriculture. And it recommended further research, especially on older clones, very few of which, it said, have been carefully studied.

Joseph Mendelson, legal director at the Washington-based Center for Food Safety, which has petitioned the FDA to delay approving cloned food, predicted that Europeans would demand marketing restrictions on the products.

'Human health is only part of the equation in Europe,' Mendelson said. 'And even if Europe gives it a green light, we believe they will require labels.'

The FDA has said it is unlikely to require that cloned food be labeled as such if no novel risks are identified.

The Biotechnology Industry Organization, a Washington-based trade group whose members include the nation's two largest farm animal cloning companies, applauded the European action and encouraged the FDA to release its long-delayed final report.

Foreign correspondent Molly Moore contributed to this report from Paris.


2.Dolly's long goodbye
Jonathan Matthews

Ten years ago this month the world first heard of Dolly the Sheep - the first mammal cloned from an adult cell. And St. Valentine's Day marked the fourth anniversary of Dolly's 'euthanasia' at the age of six after a veterinary examination showed she had a progressive lung disease, a condition more common in older sheep.

But this double anniversary doesn't round off the story. Dolly's birth at the Roslin Institute in Scotland marked just the beginning of a long production line of animal clones that has included mice, rats, rabbits, horses, mules, cats and a dog. More ominous perhaps are the cloned cattle, pigs, sheep and goats. For, while Dolly's stuffed remains are to be found exhibited in Edinburgh's Royal Museum, the push is on to serve up the remains of today's cloned livestock on our dinner plates.

Just two months ago a US Food and Drug Administration (FDA)'s draft risk assessment concluded that meat and milk from adult clones and their offspring are as safe to consume as those from standard animals. There has, of course, been no public debate about whether US citizens, let alone the recipients of US exports, wish to consume such fare, and surveys of US public opinion show a decided lack of appetite for cloned food. But we may not have the choice. The FDA has already concluded labelling should not be required while semen brokers have been busy selling thousands of units of semen from cloned bulls. Their offspring are almost certainly going to end up in the food chain. The daughter of a US cloned cow has already been born on a British farm.

The Biotechnology Industry Organization (BIO) sees no need to worry. A clone, claims BIO, is just 'a genetic twin of that animal... no genes have been changed or moved or deleted.' But clones are far from perfect copies. All clones are defective, in one way or another, with multiple flaws embedded in their genomes. Rudolf Jaenisch, a geneticist at the Massachusetts Institute of Technology, estimates that something like 4-5% of the genes in a cloned animal's genome are expressed incorrectly.

These often subtle genetic defects can have tangible consequences. Cloning produces an extraordinarily high number of deaths and deformed animals. Some clones have been born with incomplete body walls or with abnormalities in their hearts, kidneys or brain function, or have suffered problems like 'adult clone sudden death syndrome' and premature ageing. This brings us back to Dolly who developed a potentially debilitating form of arthritis at an unusually early age.

By that point, the company behind Dolly, PPL Therapeutics, had received big public funding guarantees, as Dolly became the biotech icon at the centre of what was supposed to provide Scotland with an emerging 'biotech tartan triangle' and a major economic driver. However, in the same year that Dolly died, PPL Therapeutics decided to sell its assets and shut its doors, following multimillion pound losses. It left behind a large herd of unwanted GM sheep in New Zealand that, like Dolly, had to be 'euthanised'.

But still Dolly lives on, not only in the industry of the abnormal that she gave birth to but as a 'cuddly' incarnation of the dream of a world remade without natural boundaries - limited only by our imagination and desires. While the dream may be inherently defective, it has powerful economic drivers. Cloning expert, Peter Shanks, points out that the FDA's favourable draft assessment of cloned food leaned heavily on the work of animal-cloning companies like Cyagra and ViaGen. Over a quarter of the 700-page draft, says Shanks, is a data dump from the two companies - a fact that the New York Times failed to mention, even when quoting the president of ViaGen saying, 'I think that this draft is going to provide the industry the comfort it needs.'

For Dolly and her 'descendants', it looks set to be a long goodbye.

Jonathan is the founder of GM Watch - www.gmwatch.org - and LobbyWatch - www.lobbywatch.org.

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