Concern over clones

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Related tags: Fda, Risk

The US Food and Drug Administration will revisit its preliminary determination that food from cloned animals is safe for consumers.

The U.S. Food and Drug Administration will revisit its preliminary determination that food from cloned animals is safe for consumers after several independent science advisers raised questions about the finding, a senior agency official told Reuters on Wednesday.

Biotech companies have pressed the agency to declare safe all meat and milk from cloned animals while consumer groups have expressed concerns that the FDA is moving too quickly.

Last week, the FDA issued a preliminary summary of a risk analysis that concluded food from cloned animals or their offspring were as safe as conventional food. The full report will not be released for several weeks.

But on Tuesday, several members of an FDA advisory panel of independent scientists said there was not enough data in the agency's report, especially on cloned pigs, to reach the conclusion that all milk and meat products were safe.

Stephen Sundlof, director of FDA's Center for Veterinary Medicine, said the agency still believes food from cloned animals is safe, but will review the panel's comments.

"The FDA has one opinion, but that opinion will be revisited in light of the comments of the committee,"​ he said in an interview. He said a final risk assessment, which will include the panel's comments, was expected to be published early next year.

"It was unfortunate that the FDA was unable to publish the entire risk analysis before the advisory panel met"​, Sundlof said.

"It would have been ideal, I think, if the entire document had been in a condition that it could be published. Unfortunately, it wasn't,"​ Sundlof said. "I think time will tell whether that was the right decision or not."

Another issue before the FDA, which also regulates veterinary drugs, is whether cloning poses too many health risks for the animals. The FDA report is the first step in a months-long process in deciding whether to allow the commercialization of food from cloned animals. A final policy decision is expected next year.

Consumer groups have criticized the FDA for basing its food safety conclusions on very limited scientific data.

"This decision is premature,"​ said Gregory Jaffe, biotech director for the Center for Science in the Public Interest. "They don't have the data yet to support the conclusions that they floated to the public last week."

The nascent industry, which includes leading firms such as Cyagra Inc. and ViaGen Inc., has voluntarily agreed not to sell any food products from cloned animals until the FDA makes its decision. Biotech companies clone animals by taking the nuclei of cells from adults and fusing them into other egg cells from which the nuclei have been extracted. Livestock have already been cloned for sale to producers.

Related topics: Safety & Legislation

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