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FDA says cloned food safe for sale

Milk and meat products from cloned cattle, pigs and goats and their offspring were safe for consumers to eat, according to a Food and Drug Administration document obtained by Reuters from an industry source.
/ Source: staff and news service reports

Milk and meat products from healthy cloned cattle, pigs and sheep pose no threat to people, the Food and Drug Administration claims in its first effort to address questions about the controversial technology. But that doesn’t mean Americans will be eating cloned meat anytime soon, agency officials say.

The FDA wants to gauge public reaction to the prospect of food from cloned farm animals before it decides whether to require government approval of the products before they are sold.

That decision is expected to take another year.

In a 12-page executive summary released Friday, the FDA reported: “Edible products from normal, healthy clones or their progeny do not appear to pose increased food consumption risk.”

The entire report will be released at a later date.

Meanwhile, the industry has voluntarily agreed for the last several years not to allow any products from cloned animals into the food supply, a moratorium Sundlof said the FDA expects to be upheld until it settles the issue.

The agency last year asked the prestigious National Research Council to study foods made from cloned animals. The council, an independent group that advises the government on scientific issues, concluded that cloned meat and other products seem safe.

The FDA will look two issues: Are the animals themselves healthy, and are the products nutritionally indistinguishable from those produced by noncloned animals?

By its very definition, a successfully cloned animal should be no different from the original animal whose DNA was used to create it.

But the technology hasn’t been perfected, meaning many attempts end in birth defects. The FDA acknowledged concern about the animals’ welfare in an 11-page summary of its initial review, to be posted on the agency’s Web site .

“The frequency of live normal births appears to be low, although the situation appears to be improving as the technology matures,” the review says.

Still, cloning-related birth defects aren’t that different from problems seen in the early days of other assisted reproduction techniques in farming, the FDA says.

When it comes to animals that are born healthy, there are some differences between the cloned and noncloned at young ages. “But as the animal matures, they become indistinguishable,” Sundlof said.

If it concludes cloned food products are safe, the FDA then must decide if cloning is just another form of assisted reproduction on the farm — which it doesn’t regulate — or if each product will require specific approval before selling.

Although preliminary, the FDA’s findings are causing consternation for some consumer advocates.

The FDA hasn’t yet completed writing the 300-page scientific review on which the summary is based, even though the agency is asking its scientific advisers to critique the risk assessment next week. How, critics wonder, can anyone be confident of the FDA’s review of such an important matter on the basis of 11 pages of vague information?

In addition, the FDA hasn’t yet considered the societal reaction to using cloned animals for food, something the National Research Council specifically urged addressing, said Carol Tucker Foreman of the Consumer Federation of America.

Nor is it clear that the FDA has the legal authority to stop a cloner emboldened by these preliminary findings from breaking the moratorium and selling cloned products, she said.

“They seem to be shockingly obtuse when it comes to the fact that this ... makes people very uncomfortable,” she said.

Cloned animals— which are genetically identical — are attractive to the industry because ranchers are able to keep their favorite livestock, providing better tasting meat and more milk and eggs.

The nascent food cloning industry, which includes companies such as ViaGen Inc., owned by Exeter Life Sciences, and Cyagra, is eagerly awaiting the FDA’s decision on commercialization. Smithfield Foods, the top U.S. pork producer, has a technology development contract with ViaGen.

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.

Industry officials hope the FDA will make a decision on commercialization quickly as some companies have had difficulty raising funds from investors because of the uncertainty surrounding the issue.

If the FDA does allow it, consumers are most likely to purchase meat and milk from the offspring of cloned animals, the agency said. Their parents will probably not be slaughtered for food because of their high price tag.

A cloned calf can sell for as much as $82,000. An average calf sells for less than $1,000.

Food from the offspring of cloned animals were the most likely to enter the U.S. food supply, the FDA said.

Some consumer groups have urged the FDA to address the moral and ethical concerns of animal cloning before approving its commercialization.

Consumer reaction could prove key to whether food producers want to invest in cloning technology or not. Foods that are genetically modified face trade barriers overseas despite FDA assurances that those now sold are safe. While cloning means a genetic copy, not genetic modification, public understanding of biotechnology is sketchy.

“If these products are safe, is the consumer confident in that?” asked Stephanie Childs of the Grocery Manufacturers of America. “We’re definitely examining this issue very closely.”

The Associated Press and Reuters contributed to this report.