FDA: Cloned Animals Safe to Eat

Critics say agency ignores scientific, ethical issues

FRIDAY, Oct. 31, 2003 (HealthDayNews) -- Federal officials moved a step closer Friday toward allowing products from cloned animals into the U.S. food supply.

The U.S. Food and Drug Administration released a draft executive summary of a risk assessment of food products from animal clones that found them to be safe for human consumption.

"Food products derived from animal clones and their offspring are likely to be as safe to eat as food from their non-clone counterparts, based on all the evidence available," reads a statement from the FDA. "These scientific findings also showed that healthy adult clones are virtually indistinguishable from their conventional counterparts."

The document builds on a National Academy of Sciences report commissioned by the FDA two years ago. The report, which was released last year, concluded that while the safety risk from food from animal clones appeared to be low, more data was called for.

"We are now evaluating the entire body of scientific literature on this subject and reducing that to a risk assessment model that the Veterinary Medicine Advisory Committee will comment on next week before we finalize it," Lester Crawford, deputy commissioner of the FDA's Center for Veterinary Medicine, said at a news briefing Friday. That committee meeting is scheduled for Nov. 4.

The full risk assessment is expected to be released to the public by the end of this year or the beginning of 2004. It will them be open for public comment.

Critics, however, are crying that the sequence of events is extremely premature.

"The message they sent is that these products are safe, and I simply think that that is not a justified statement to have made," said Carol Tucker Foreman, director of food policy for the Consumer Federation of America in Washington, D.C.

"The National Academy of Sciences said we don't think there are problems but there are scientific questions that are unanswered, and the FDA should not go forward before addressing the questions," continued Tucker, a former assistant secretary of agriculture, where she oversaw meat and poultry inspection. The agency, in her opinion, "hasn't addressed them."

Foreman is troubled not only by the science, but by a process that was repeatedly described by the FDA as "orderly and transparent."

"There is no risk assessment," she said. "They're releasing an 11-page summary of a 300-page document that doesn't exist yet."

According to statements made at the news briefing, only about half a dozen places actually clone animals for eventual use in the food supply. A voluntary moratorium on consumption and sale of food from these animals is in effect and will remain in effect, Crawford said.

FDA officials would not speculate when, if ever, the voluntary moratorium would be lifted. "It depends on how the risk assessment goes," Crawford said. "If the assessment and the public commentary conclude that these animals are safe and that their offspring are OK to enter the market, we could be making a decision at some point in the fairly near future."

The draft document does not address ethical issues, although the FDA stressed that it will not ignore this dimension.

"Essentially what we're doing now is evaluating the risk involved from the scientific point of view, but we do recognize that there are societal concerns about this technology as there is about some related technology," Crawford said. "We expect that there will be public comment to this effect. The FDA will consider those comments from the public."

For Foreman, however, this is not enough. "Every poll that's out there says that at least 60 percent of the public opposes animal cloning. For many, they think the next step is human cloning," she said. "If you really want to rise above that argument, you have to have a process that is reassuring to the public. It's not enough to say, 'Don't be ridiculous.' "

But the current process and release of information may not be geared exactly for the public, Foreman added. She can't fathom why the information was released at this time, but she does speculate.

"Most of the companies doing animal cloning are small and having trouble getting capital. I think this was intended to help them because they have been complaining bitterly that failure to act was putting them out of business," she said. "I don't think that this action will in the long run serve the industry well. I don't think it will serve the FDA well. It sure as hell won't serve the public."

More information

To see the draft executive summary, visit the Food and Drug Administration. The University of Georgia has an article on the "promises and perils" of livestock cloning.

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