010614 FDA Mulls Regulating Cloned Animals

Washington - The government is deciding whether to regulate cloned livestock and wants assurances that the animals' meat and milk are safe and that the technology doesn't harm the animals or the environment.

A study by the National Academy of Sciences of the technology's safety is due early next year. The Food and Drug Administration will use the results to decide whether cloned animals will require government approval before they are sold for food.

“We're trying to make a science-based decision on whether these types of animals pose any risk,” John Matheson, a senior regulatory review scientist for the FDA, said Tuesday.

Biotech companies have been asked to keep the livestock out of the food chain until the agency finishes its review. As a practical matter, however, industry experts say it will likely be years before cloned farm animals or their progeny are ready for food use. The cattle and pigs that have been cloned so far are either for breeding or medical uses.

“They are really in the experimental stage yet,” said Ken Olson, an animal health specialist who has advised the American Farm Bureau Federation, a major farm organization.

The FDA believes it has the authority to regulate cloned animals under its approval process for new animal drugs.

Essentially, FDA is deciding whether cloned animals should be treated like genetically engineered animals, which are regulated by the FDA, or like animals bred through in-vitro fertilization, which don't require FDA regulation.

“We figure there is a pretty good chance there won't be a need to regulate them,” Matheson said.

One concern of scientists is that mass animal cloning could lead to breeds that are more susceptible to disease.

The clone of a Holstein dairy cow was sold at auction last fall in the first commercial sale of a farm animal.

The company involved, Infigen Inc. of DeForest, Wis., has cloned 120 beef and dairy cattle, either for breeding or for making genetically engineered proteins for pharmaceuticals. Several dozen piglets also have been cloned in an effort to develop organs and tissue that can be transplanted into humans.

Infigen is currently studying the milk from cloned cattle to see if it is different from milk produced by conventional cows and will provide the results to FDA, said company spokesman Peter Steinerman.

“The bottom line is that they (FDA officials) want to make everyone comfortable that these animals are normal in every respect. Any studies that are needed in that the company will do,” Steinerman said.

Infigen's cloning process involves activating an unfertilized egg by removing the nucleus, fusing the egg with a cell from the same animal's ear, and then using a chemical compound to trigger a release of calcium that causes the egg to divide and grow. The resulting embryo is then implanted in a surrogate cow.

Researchers at the University of Tennessee are investigating the death of a cloned cow Monday at the university's Knoxville experiment station. Except for a slight variation in the size of a kidney, the cow showed no visible signs of abnormalities, said veterinarians who examined the animal.

RETURN TO HOME PAGE

E-mail: sflanagan@sprintmail.com