Federal regulators may soon release a decision on whether meat and milk from cloned animals and their offspring are safe for human consumption.

The decision is widely expected to conclude that cloned livestock pose no risk to humans. It is being eagerly anticipated by both industries eager to use clones to vastly cut the cost of food production and by food safety groups who warn that declaring clones safe is premature.

FDA senior scientist John Matheson told attendees of a biotechnology conference last week that the FDA's four-year evaluation could be released any day. The remarks were originally reported by the Financial Times newspaper.

"I do expect it to be very soon. 'Very soon' when you're dealing with an FDA guidance could be this week or could be two months from now," says Scott Davis, president of stART Licensing, Inc., a company that patents cloning technologies for livestock, including the patent used to clone Dolly the sheep, the first successfully cloned mammal. Davis hosted the conference where Matheson reportedly made the comments.

"We're not ready to make an announcement," FDA spokeswoman Suzanne Luber says.

Many livestock producers have been waiting to use cloning as a way to copy breeding animals prized for their genetic and physical traits. Producers have so far held off using cloned animals in commercial food production at the FDA's request.

Read WebMD's "Cloned Food: More Study Needed"

Reports Favor Cloning

A draft FDA assessment in October 2003 stated that cattle, pigs, sheep, and goats "derived from animal clones and their offspring are likely to be as safe to eat as food from their nonclone counterparts, based on all the evidence available."

The conclusion echoes a 2002 National Academy of Sciences study, which found "no current evidence" that food derived from clones or their offspring posed a safety risk.

Meat and dairy producers want to use clones to cut costs and to remove much of the guesswork from choosing prime breeding animals.

A prize breeding bull can cost upwards of $130,000 at auction, while cloning an existing bull costs about one-sixth the price, says Leah Wilkinson, director of food policy at the National Cattlemen's Beef Association. In addition, cloning can cut as much as three years from the time it now takes to select prime breeding animals from herds.

"Everything we've seen is that beef from cloned offspring is safe. There's no difference in nutrition and it's the same as regular beef," she says.

Cloned livestock are not genetically modified to express favorable traits. Instead, they are copies of animals deemed the most favorable for breeding because of the tenderness of their meat, ability to produce milk, or other qualities.

Read WebMD's "Cloned Meat: At Your Supermarket Soon?"

Safety Concerns Voiced

But food safety advocates warn that it's too early to conclude that cloned animals or their offspring are safe for human consumption. They remain especially concerned about the process of somatic cell nuclear transfer, in which genetic material is inserted into a host body cell, eventually producing an exact copy of the genetic donor.

Craig Culp, a spokesman for the Center for Food Safety, says that not enough studies directly comparing meat from animals cloned using somatic nuclear transfer -- or their offspring -- with conventionally bred animals have been performed.

Culp points to the "typically sickly nature" of many cloned newborn mammals and to a lack of studies on potential abnormal genes in clones as areas of concern. The group also questions the ethics of using cloning to homogenize animals used in the food supply.

"There are a lot of issues that have not been addressed, and a decision from the FDA to approve this would be highly premature," he says.

LawrenceB. Schook, PhD, a member of the 2002 NAS committee, tells WebMD that there was "very little concern" on the panel for the safety of nongenetically modified cloned animals or their offspring. "If the animal grows healthy, can reproduce itself, grows and acts normal, then it is normal," says Schook, an expert in animal genomics at the University of Illinois, Urbana-Champaign.

Schook is also co-founder of Pryxis, a private animal genomics company.

Davis, who is also founder of the animal cloning company ViaGen Inc., tells WebMD that his firm submitted tests to the FDA comparing approximately 600 cloned pigs and their offspring with conventionally bred animals. The study found "not one" significant difference in nutritional content, he says.

Even if the FDA approves the sales, consumers' acceptance of cloned farm products remains an open question. Internal polling at stART suggests about 60 percent of U.S. consumers are uncomfortable with cloned animals or their offspring in the food supply. But the government's stamp of approval on the animals lowers disapproval to around 40 percent.

The FDA approval will also likely set off a battle between meat producers and consumer groups over whether clone-derived products should be labeled as such on grocery store shelves.

"At some point I could see a labeling fight would be forthcoming," Culp says.

Read WebMD's "'Superfoods' Everyone Needs"

By Todd Zwillich, reviewed by Michael W. Smith, MD

SOURCES: Scott Davis, president, stART Licensing, Inc. Suzanne Luber, spokeswoman, FDA. Leah Wilkinson, director, food policy, National Cattlemen's Beef Association. Craig Culp, spokesperson, Center for Food Safety. Lawrence B. Schook, professor of genomics, University of Illinois, Urbana-Champaign; co-founder, Pryxis.