Labels Weighed for Food From Clones
Consumer Groups Doubt FDA's Risk Management Plan Will Keep Pace With Industry

By Rick Weiss
Washington Post Staff Writer
Sunday, January 20, 2008

With the Food and Drug Administration having declared that meat and milk from cloned animals are safe, opponents of food from clones are shifting their fight to how such fare is labeled.

Although the FDA said last week that it will not require special labels on foods from clones, legislation already introduced in the Senate could force the agency's hand. Short of that, many consumers are demanding that the agency allow food from conventional animals to be labeled "clone-free" -- a marketing move that could dash industry hopes of getting beyond the public debate over clones.

Separately, some consumer groups are wondering aloud how the FDA will live up to its promise to keep an eye on the quickly evolving field of animal cloning and protect the public from unexpected problems.

The agency has a strategy for doing so, laid out in a "risk management plan" released last week alongside its larger "risk assessment." But its plans depend heavily on the cooperation of the companies making the clones, an approach that critics say is less than reassuring.

Bruce I. Knight, undersecretary for marketing at the U.S. Department of Agriculture, which now has the task of helping to get food from clones to the market, expressed optimism last week that producers and consumers will find common ground.

"We'll be working closely with stakeholders to ensure a smooth and seamless transition into the marketplace for these products," Knight said.

Yet skirmishes seem certain.

A fight over labeling is perhaps the surest -- one likely to be led in part by Sen. Barbara A. Mikulski (D-Md.), who has introduced legislation that would require labels.

Clone companies oppose labels, seeing them as little more than a tool to help wary consumers avoid clone-derived products. Companies note that meat and milk products from conventionally bred animals are not labeled with details about how those animals were conceived. And the FDA has generally reserved mandatory labeling for things that present a real risk.

But even if calls for labeling fail, the FDA could respond to public pressure with the clone-free labels for products not from clones.

The FDA may allow such labels, even in the absence of safety concerns, if the claims on the labels can be verified. That is a difficult bar to clear for clone-free milk and meat because those products are chemically indistinguishable from their equivalents made from clones. But there is a precedent.

Years ago, the FDA relented under consumer pressure and allowed special labels on dairy products from animals that are not treated with recombinant bovine somatotropin (rbST), a hormone that some farmers give their cows to boost milk production.

Milk from cows treated with rbST is indistinguishable from untreated cows' milk. But the agency accepts the assurances of an independent verification system that tracks untreated cows, and allows the labels as long as they do not suggest that one product is more wholesome than the other.

Recent events in the United States and Europe have given consumer advocates hope that the FDA may allow such labels on food not from clones.

Responding to a public outcry, the Pennsylvania Department of Agriculture reversed a plan that would have banned those now common "No rbST" labels.

Under similar pressure from consumers and regulators, the nation's two largest producers of cloned cattle -- ViaGen of Austin and Trans Ova Genetics of Sioux Center, Iowa -- recently announced that they would create a registry of all farm animal clones and a system for keeping them out of the mainstream food chain. The registry could become a verification system for clone-free labels.

And in Europe last week, an ethics board that advises the European Commission recommended that food from cloned animals not be allowed on the market until, among other things, a labeling system has been put in place to help consumers avoid food from clones if they choose to.

Less clear at this point is whether it will be practical to label products as not having been made from the offspring of clones, which are far more likely to enter the food supply than clones themselves.

Jim Greenwood, president of the Biotechnology Industry Organization, said he is "perfectly comfortable" with clone-free labels, "as long as they are truthful and don't mislead consumers." He also believes food from the offspring of clones should be eligible for the clone-free label. Even the European report conceded that a program covering the offspring would be technically daunting because of the complex genealogy records that would have to be kept.

Apart from labeling, some advocacy groups are raising concerns about how the FDA will keep up as the food-from-clones sector grows.

The agency concedes that its assurances that food from clones is safe are based on the particulars of methods clone-makers are using today -- methods it says are likely to change in coming years.

"Significant changes in cloning technology . . . would significantly increase the uncertainty associated with our judgments," the FDA concluded in its 968-page risk assessment.

But the agency's plan to keep abreast of such changes is less than reassuring, said Margaret Mellon of the Union of Concerned Scientists in Washington, an advocacy group.

That strategy, spelled out in the agency's nine-page risk management plan, comes down to: Keep in touch with scientific and veterinary groups by, for example, attending periodic professional gatherings; and stay up on the science by reading the latest journal articles.

The plan also "strongly encourages" cloning companies to tell the FDA when they change methods, so the agency can consider whether the changes raise new safety concerns.

"What I want to know is what regulatory authority are they invoking here, and what does that authority allow them to do?" Mellon said. "Does it allow them to require the companies to disclose any new methodologies or problems? Is the FDA going to have to wait until it reads about these changes in the scientific literature? Because by then, it's going to be way too late."

Asked whether the FDA is equipped to find out about unexpected problems from cloned food, given that so much of the science is proprietary, and whether FDA is empowered to act on any problems that arise, the agency's new director of veterinary medicine, Bernadette Dunham, said she could and would act quickly.

"We would have them pulled," Dunham said without specifying how the agency would distinguish clone products from others unless some kind of labeling were in place.

"I do believe we'd be able to respond if we saw anything of an adverse nature."

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