By Rick Weiss
Washington Post Staff Writer
Friday, December 29, 2006
Taking a long-awaited stand in an emotionally fraught food fight, the Food and Drug Administration yesterday released a 678-page analysis concluding that milk and meat from cloned animals pose no unique risks to consumers.
The decision, subject to change after a period of public comment, stops short of approving the sale of food from clones and leaves in place for now a long-standing government request that farmers keep their clones off the market.
But it represents a crucial milestone for the handful of biotechnology companies that see cloning as a welcome opportunity to sidestep the vagaries of sexual reproduction and instead mass-produce some of the nation's finest meat- and milk-producing animals.
"The higher-end breeders are going to start signing up and taking advantage of this," said Mark Walton, president of Austin-based ViaGen, which has produced about 250 cloned cattle and pigs in preparation for what the company hopes will be a robust market in farm clones. "They've been interested, but they've been skeptical that we'd ever get the regulatory process dealt with."
Opponents, however -- including some who doubt the safety of cloned food and others concerned about the welfare of the animals -- vowed to fight the new momentum toward approval.
"This is a lose-lose decision for consumers and the dairy industry," said Joseph Mendelson, legal director at the Center for Food Safety in Washington, which has petitioned the FDA to regulate cloned farm animals one type at a time, much as it regulates new drugs.
Release of the draft risk assessment was delayed for years, in part by a coalition of big-name dairy companies concerned that the "yuck factor" surrounding cloned animals might tarnish milk's image and undermine sales. Surveys have consistently found that a majority of consumers are wary of food from clones, with many saying they would avoid it.
Yet study after study reviewed by the FDA failed to find any scientific reason to keep meat or milk from clones off store shelves.
"Extensive evaluation of the available data has not identified any food consumption risks or subtle hazards in healthy clones of cattle, swine, or goats," the FDA risk assessment concludes.
In apparent recognition of consumer distrust of cloned food -- and of widespread public misunderstanding about the science of cloning -- the agency posted on its Web site not only the detailed technical report but also several lay-language documents that aim to debunk negative "myths" about clones, which the agency notes are copies of existing animals and are not engineered to have new traits.
The agency also took the unprecedented step of posting all the raw scientific data it used to come to its conclusion, along with unedited copies of comments it received from independent experts who were asked to review the report in advance.
"We have looked very, very closely," Stephen F. Sundlof, the FDA's chief of veterinary medicine, said in a telephone news conference. "There's just not anything there that is conceivably hazardous to the public health."
Sundlof declined to predict when the agency might come to a final decision. With public comment allowed through April 2, and with the agency's need to thoroughly review those comments, a decision could come by the end of 2007, he said.
Even if a positive decision sails through, consumers will have to wait awhile for their first clone burger. Fewer than 1,000 cloned animals are living on U.S. farms, out of tens of millions of cattle and pigs. And it takes about two years to produce a cloned steer for slaughter and even longer to grow a cloned dairy cow old enough to be milked.
Moreover, with price tags up to $15,000 apiece, clones are currently too valuable to kill or milk directly. So most will initially be used as breeding stock to make high-quality offspring for slaughter or milking, a process that will take an extra couple of years.
"Everything is basically two to three years away, even if it all opens up tomorrow," said Steve Mower, director of marketing at Cyagra, a livestock-cloning company in Elizabethtown, Pa.
To make a clone, scientists take a single skin cell from an animal they want to replicate. They fuse it with a cow egg that has had its DNA removed, resulting in the creation of an embryo that can be transferred to the womb of a surrogate mother animal. The resulting newborn is a twin of the animal that donated the initial cell.
Opponents of food from clones note that the animals harbor subtle molecular differences in their DNA as a result of having been produced from a single parent. They also point to higher rates of problems during fetal development, resulting in birth defects and a high miscarriage rate, which in turn poses risks to the surrogate mother.
Some also question the economic sense of using cloning to make superproductive dairy cows.
Carol Tucker Foreman of the Consumer Federation of America said U.S. farmers produce more milk than Americans can drink, and the government must buy the surplus. "Since 1999, dairy support programs have cost taxpayers over $5 billion," she said in a statement.
Supporters counter that DNA differences in clones do not translate into discernible differences in the chemical composition of their milk or meat, as shown in many studies that have measured thousands of variables, including protein, fatty acid and vitamin levels.
The developmental problems are not different from those seen in animals produced by commonly used assisted reproductive techniques such as in vitro fertilization and artificial insemination, FDA officials said. And although the rates of those problems are higher in clones, they are declining as techniques improve.
Although some may doubt that cloned food is cost-efficient -- and others worry that the presence of cloned products in the U.S. food supply could hurt exports if other countries, none of which has approved food from clones, reject those products -- economics are not under the FDA's purview, officials said.
In conjunction with the risk assessment, the FDA yesterday released a risk-management plan, which outlines how the agency would track newly emerging concerns about food from clones in coming years. It includes a proposal to create a publicly accessible database of all new findings as companies scale up their operations.
Although ViaGen and Cyagra volunteered large amounts of data to the FDA for its risk analysis and have offered to continue cooperating, officials at both companies said this week they will have to consider whether they can promise public release of all their findings.
Several groups are pushing for a requirement that cloned food be labeled as such, allowing consumers to avoid it. Sundlof said such labels would be inconsistent with a long-standing FDA policy to reserve labels for scientifically substantive issues. But he said the agency would be open to "clone-free" labels on foods that come from other sources.
Congress could also get involved. This month, Sen. Patrick J. Leahy (D-Vt.) and six other senators wrote to Health and Human Services Secretary Mike Leavitt, asking that the FDA run the new risk assessment past an additional scientific review board and study the global trade implications.
In statements released yesterday, Leahy and Sen. Barbara A. Mikulski (D-Md.) -- who has expressed reservations about food from clones -- encouraged Americans to send their opinions to the FDA.