More clone data needed

The US Food and Drug Administration (FDA) is promising to come up with more studies on the safety of food products derived from cloned animals after half the members of a key advisory committee said last week that they didn't have enough information to sanction the move. “We promised to get the information out to the committee by the end of this year,” said Stephen Sundlof, director of the FDA Center for Veterinary Medicine. The FDA is under pressure from the nascent cloning industry to treat meat and dairy products from cloned animals and their offspring the same as other food. A staff report released in late October said that the FDA's review of the scientific literature turned up no evidence that food products derived from cloned animals should be regulated, or even labeled.But several scientists at last week's Veterinary Medicine Advisory Committee meeting were deeply troubled by the lack of scientific evidence backing the staff report. “The assumption made was that there would be no problem, but they didn't present any real evidence one way or the other,” said Sherman Jack, a professor of pathobiology at the College of Veterinary Medicine at Mississippi State University. “The FDA made a plea several times during the hearing that [the industry] come up with more data.” The FDA usually follows the recommendations of its outside advisory committees. Top FDA officials are confident that they will be able to answer the questions raised by the 12-member advisory committee. Sundlof said the FDA still plans to make its final cloned foods risk assessment available for public comment before the end of the year. If the assessment concludes the risks are minimal, the FDA's risk management strategy, which it hopes to release next spring, could forgo additional regulation or labeling. “We have not identified any hazard that is contributed by the cloning process to this point,” Sundlof said. “We still need to know if the food is identical. The information presented this week suggested it is not different from traditional foods.”The major roadblock is the paucity of studies. There are only a handful of companies involved in cloning. And since cloning a single cow or pig under existing technology costs nearly $20,000 and companies have voluntarily held off from introducing the progeny of cloned animals (their most likely use) into the food supply, there are very few animals to test. “Most of the data presented this week was based on the result of one company's work,” said Jack. “There's no evidence yet to base a go/no-go decision.”The one consumer advocate on the committee, Richard Wood of the Chicago-based Food Animal Concerns Trust, echoed Jack's concerns about the lack of data on food safety. He also questioned whether the FDA was the only agency with the authority to regulate food derived from clones.Several outside consumer groups that testified at the hearing suggested the Department of Agriculture should require labeling on food products derived from clones. Even the Environmental Protection Agency may be asked to get involved. “Does this cloning process change the flora in the guts of the clones, and does this change the pathogen mix in such a way that it represents a threat to humans once it is in the environment?” Wood asked. “We need more data.”Demands for more studies and the specter of court challenges to the FDA's sole jurisdiction over cloned foods could postpone their arrival until 2005 or later.

More clone data needed

FDA advisory committee not satisfied with available data on cloned animal products

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