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Published on Friday, January 4, 2008 by Wall Street Journal

Cloned Livestock Poised To Receive FDA Clearance

by Jane Zhang, John W. Miller and Lauren Etter

Get ready for a food fight over milk and meat from cloned animals and their offspring.After more than six years of wrestling with the question of whether meat and milk from them are safe to eat, the Food and Drug Administration is expected to declare as early as next week that they are.

The FDA had asked producers of cloned livestock not to sell food products from such animals pending its ruling on their safety. It isn't clear whether the FDA will lift this voluntary hold.

While many consumer groups still oppose it, the FDA declaration that cloned animal products are safe would be a milestone for a small cadre of biotech companies that want to make a business out of producing copies of prize dairy cows and other farm animals -- effectively taking the selective breeding practiced on farms for centuries to the cutting edge.

Because of the price tag -- cloned cattle cost $15,000 to $20,000 per copy -- most of the cloned animals will be used for breeding, and it will be three to five years before consumers see milk and meat from their offspring. Some animal breeders in the U.S. have already been experimenting with cloning animals. ViaGen Inc., the largest animal-cloning company in the nation, has cloned animals, such as a cow named Peggy Sue.

Consumer wariness toward cloned food may lead to a backlash from opponents in Congress and other markets, such as the European Union, who are concerned that not enough data are available for a viable study on the safety of the products. There are also ethical worries because cloned animals tend to have more health problems at birth than conventionally bred animals.

The food industry appears to be divided over the issue. Some big food companies say they're not interested in trying to market products from cloned animals or their offspring.

"Most consumers do not find this appealing," says Marguerite Copel, vice president of corporate communications at Dean Foods Co., one of the nation's largest milk producers, which says it won't sell any milk from cloned animals.

Dean and others in the food industry are also worried that there is no mandatory tracking system in place for products from clones or their progeny. The Food Marketing Institute, which represents food retailers and wholesalers, says its members tend to "strongly believe" that they must be notified if any of their suppliers intend to introduce cloned animals into the food supply.

"Whole Foods Market is committed to providing consumers with clone-free products," says Margaret Wittenberg, global vice president of quality standards and public affairs for grocer Whole Foods Market Inc. "The lack of effective governmental oversight and tracking could mean consumers will lose the ability to choose clone-free products."

ViaGen and Trans Ova Genetics, another of the three livestock-cloning companies in the U.S., recently announced a voluntary tracking system that will help food makers, slaughterhouses and marketers to prove, if they choose, that they aren't selling such foods. The program doesn't cover the offspring of clones, however.

Jeffrey Barach, vice president at the Grocery Manufacturers Association, the largest trade group for the food and beverage industry, says that as consumers become more educated, they'll become more accepting of such products, if they even notice them.

The meat industry is more bullish on cloned products than the dairy industry. The American Meat Institute Foundation, which represents large meat companies like Smithfield Foods Inc. and Hormel Foods Corp., thinks consumers might even come to appreciate the technology when they find superior products in the grocery-store freezer, like leaner and larger cuts of meat. For producers it might mean cows that have fewer calving problems or greater milk production.

"These animals are not some kind of freaks of nature," says James Hodges, president of the group.

But Tyson Foods Inc., also a member of the institute and one of the nation's largest producers of beef, says the company "currently has no plans to purchase cloned livestock, especially since it will likely be a long time before such animals" are available for market.

The FDA tentatively ruled in 2006 that milk and meat from cloned cattle, swine and goats are no different from healthy, conventionally bred adult animals. The agency has called cloning merely "a more advanced form of" breeding technologies already widely used in the cattle industry, such as artificial insemination, embryo transfer and in vitro fertilization.

Consumers, however, have a long history of turning up their noses at technological innovations in food. It took years for consumers to accept pasteurized milk as safe. Some consumers and consumer groups still refer to genetically altered foods, like those that contain genetically modified corn or soybeans, as "Frankenfood" even though such products have been on the market for more than a decade.

Many consumer groups and some members of Congress are vehemently opposed to cloned foods reaching grocery shelves. The Senate version of the proposed farm bill contained an amendment from Sen. Barbara A. Mikulski (D., Md.,) that would mandate that the FDA wait until further studies are done before releasing its final assessment of food from cloned animals.

Joseph Mendelson, legal director of Center for Food Safety, a consumer-advocacy group, said his group has filed a petition for the FDA to regulate cloned animals as an animal drug, as it is considering with genetically modified animals. (Clones are genetically identical copies and the sequence of their genes are not modified.)

"Once the FDA says these products are safe and that they are out there, it's very hard to turn it back," Mr. Mendelson said.

The FDA's decision has been closely watched by regulators around the world. There are already livestock clones in countries such as Australia, Canada, France, Japan and New Zealand, but they have rarely entered the food supply.

The European Food Safety Authority, the European Union's version of the FDA, will likely deliver its initial assessment on food from cloned animals next week, but the final decision won't come for several months. In addition, a special commission called the European Group for Ethics is conducting its own studies on the question of whether cloning is inhumane.

U.S. food companies could face more trouble from European Union regulators and consumers, who are unlikely to respond favorably to the idea of eating cloned animals or their offspring. According to a recent poll, 55% of Italians think the EU should ban food made from cloned animals.

The EU already bans most meat imported from the U.S. because it's often raised using hormones. (It imports only $70 million worth of meat a year from the U.S.) Similarly, trade rules allow the EU to ban the import of cloned animal food if it's for health and safety reasons.

Different regulatory approaches across the Atlantic may affect trade, especially in the EU dairy sector. The EU is the world's biggest dairy exporter, at $33 billion a year, and farmers need the best producing cows to stay competitive. Currently, the best breeders are in the U.S., and the EU buys $23 million worth of bull semen from the U.S. every year.

European breeders are worried that a ban on any derivatives of cloned animals would limit their access to the world's most productive cows. The European Forum of Farm Animal Breeders is lobbying the EU to make an exception for bull semen, even if it bans other types of cloned animal products.

"Product from cloned animals cannot be distinguished from non-cloned," it wrote in a recent letter to the EU Commission.

Write to Jane Zhang at Jane.Zhang@wsj.com, John W. Miller at john.miller@dowjones.com and Lauren Etter at lauren.etter@wsj.com

© 2008 The Washington Post

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