"If people insist on putting them into the food supply ... before the report is out, we would recommend that they come into us with an investigational application first, just to be on the safe side"  --  John Matheson, Senior Regulatory Scientist, FDA Center for Veterinary  Medicine

"Infigen's first cloned cows whose milk might go into the food supply are due to be born in September." -- Peter Steinerman, Infigen Inc.  Spokesperson
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Fencing in the Herd
from the Wall Street Journal

The marketing of cloned animals has prompted regulatory concern, as some companies are seeking to make a business out of this evolving technology. A sample of those companies:

Company                         Description

Advanced Cell Technology     Began marketing cloning services to dairy farmers last year. Each animal costs about $25,000.  

Genzyme Transgenics     Cloned goats that produce a human clotting factor in their milk.  

Geron       Acquired the technology used to create Dolly the sheep in a 1999 merger with closely held Roslin Bio-Med.  

Infigen      Has produced dozens of cloned cattle and pigs.

PPL     Working on cloning genetically engineered pigs for animal-to-human-organ transplants.
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FDA : Cloned Animals Not OK'd As Food
June 6, 2001
By PHILIP BRASHER
AP Farm Writer
WASHINGTON (AP) via NewsEdge Corporation -

The Food and Drug Administration says it doesn't want meat or milk from cloned livestock sold to consumers until it is sure the food is safe and the technology won't harm the environment or the animals.

``We're trying to make a science-based decision on whether these types of animals pose any risk or not,'' John Matheson, a senior regulatory review scientist for the FDA, said Tuesday.

In a series of meetings over the past six months, FDA officials have asked biotech companies to keep the livestock out of the food chain until the National Academy of Sciences completes a review of their safety and makes recommendations to FDA. The study is expected to be finished by early next year.

The FDA is concerned about the welfare of the cloned animals as well as their safety for humans and the environment. The agency believes it has the authority to regulate cloned animals under its approval process for new animal drugs.

Essentially, the agency 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 Wall Street Journal reported Tuesday.

A Holstein dairy cow cloned by Infigen Inc. of DeForest, Wis., was sold at auction last fall in the first commercial sale of a farm animal. Infigen also owns a herd of cloned cattle that are used to produce genetically engineered proteins for pharmaceutical purposes.

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.