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Cloned Food Approval May be on Hold

Jan 7, 2008 | Parker Waichman LLP Cloned animal foods might not be getting a regulatory stamp of approval just yet.  The U.S. Food and Drug Administration (FDA) may consider delaying a decision on whether milk and meat from cloned animals are safe foods pending a Congressional review of legislation requiring the agency to conduct additional testing.  Clones are genetically identical copies whose gene sequencing is not modified and, while many consumer groups oppose cloning, the FDA announcement would be a milestone for a small group of biotech companies that want to replicate prize animals.  "The biggest question mark is the language that is in the (Senate) farm bill," said Gregory Jaffe with the Center for Science in the Public Interest. "If that becomes law, that would change the whole dynamic of when this is decided."  The FDA ruled—in a draft decision in December 2006—that food and milk derived from cloned cattle, pigs, and goats was safe to eat.  Many expect the FDA to permit their sale once they make a final announcement.  An FDA spokesman said the agency is still working on its report and could not offer a date when it would be completed.

The Senate farm bill that passed in December included a measure from Senator Barbara Mikulski directing the FDA to complete further review and analysis before issuing a final decision. A similar provision was in the multibillion-dollar spending bill that passed in Congress last month.  Lawmakers from the Senate Agriculture committee are expected to meet with their counterparts in the House, which did not include a cloning provision, later this month to craft a final bill.  Mark Walton, president of Via-Gen, the nation’s largest cloning company, said the existing science supports the safety of cloning, saying "I was surprised and disappointed to see somebody like Senator Mikulski, who has a history and track record of being supportive of the scientific process and science regulation, coming out because of social and political concerns saying 'I don't think we ought to do this,'" Walton said.

Proponents say cloned animals are safe and hope technology will create disease-resistant animals that produce more milk and better meat while opponents have urged the FDA to delay its final ruling until more studies can be conducted on cloned animal product safety.  The cloning industry has said products would come from the offspring of cloned animals, which they view like offspring from traditional animals.  Cloned cattle cost around $20,000 each, so their high price will result in most being used for breeding and it will be three to five years before consumers see milk and meat from cloned offspring.  Groups on both sides say the FDA has not received enough new data in the last year that would lead it to reverse its preliminary decision.  "They've made their decision and they are going to try as they can to move forward with it," said Michael Hansen, a senior scientist at the nonprofit Consumers Union. "The science still isn't there to say that meat and milk from clones and their offspring is safe," he added.  At present, these products cannot be sold, and a voluntary ban remains in place until a final ruling is issued.

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