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FDA to declare safe meat and milk from clone animals

Financial Times | June 22, 2005
By Clive Cookson

Meat and milk from cloned farm animals is about to be declared safe for human consumption by the US Food and Drug Administration, one of the world's most powerful regulatory bodies.

A favourable risk assessment from the FDA is expected to start the commercial exploitation of cloning to improve livestock quality around the world.

FDA officials told the BIO 2005 biotech industry conference they had completed a four-year assessment process and concluded that cloned animals and their progeny would be as safe to eat as conventionally bred animals. They also found that cloning was acceptable from the viewpoint of animal welfare.

Scientists said the first pork and beef from cloned animals could reach the market next year. John Matheson, senior regulatory scientist at the FDA, said uncertainty in the US government about the ethics of animal cloning had delayed publication of the assessment.

But Mr Matheson said he expected the assessment to appear any day.

“The FDA would want the ethics to go away but there are people with legitimate concerns about the impact of this technology,” he said.

At the FDA's request, agricultural biotechnology companies and the livestock industry have been observing a moratorium on the commercial introduction of meat and milk from cloned animals and their offspring.

Mr Matheson said this should continue until the assessment had been published and was then revised after a two-month period for public comments. Irina Polejaeva, chief scientist for ViaGen, a leading animal cloning company, said other countries with strong livestock sectors such as Australia and New Zealand were waiting for the FDA assessment.

She said meat from cloned animals could be on sale next year. The public still imagined that animal cloning was an inefficient process that produced unhealthy animals, Ms Polejaeva said. But cloning procedures had improved greatly during the eight years since Ian Wilmut and colleagues at the Roslin Institute in Scotland first used them to produce Dolly the sheep.

Larisa Rudenko, FDA senior biotechnology adviser, said that although cloned animals were more likely to suffer birth defects and health problems when very young, after about 50 days old they were as healthy as animals conceived conventionally. The FDA assessment analysed the biochemical composition of meat and milk from cloned animals and their offspring and found it was the same as that from conventional animals.

ViaGen and Cyagra, another US-based livestock cloning company, supplied much of the data for the assessment. Between them, the two companies have produced several hundred cloned pigs and cattle.

In practice most meat and milk would not come from clones themselves, which would be used to improve the agricultural gene pool, but from their progeny. MsRudenko said: “Clones are for breeding not for eating.” Alejandro Cantarelli, Cyagra's chief executive, said a lot of people confused animal cloning with genetic engineering. “A clone is not a transgenic animal; it is a genetic replica of the founder animal,” he said.

Roslin Institute's original Dolly cloning patents are now owned by Start Licensing, a Texas-based company set up in April to find commercial applications for animal reproductive technologies.


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