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FDA appeals mandate to ban three animal antibiotics.

After a magistrate ruled that the Food and Drug Administration must act on its long-standing proposal to ban the use of three antibiotics in animal feed because they may contribute to antibiotic resistance in bacteria, the agency has decided to appeal the decision.

In a notice dated May 21, FDA Commissioner Margaret Hamburg, Director of the Center for Veterinary Medicine Bernadette Dunham and Secretary of Health and Human Services Kathleen Sebelius together filed an appeal with the Second Circuit Court of Appeals to overturn the March decision.

The judge's order would require FDA to restart a process it began in 1977 but never completed and formally ended in December in advance of announcing the voluntary plan. The order came in a lawsuit filed by several environmental and public health groups, including the Natural Resources Defense Council, Center for Science in the Public Interest and Union of Concerned Scientists. The plaintiffs argued that banning the use of penicillin and two types of tetracycline in animal feed should go forward in light of evidence that this practice was contributing to antibiotic-resistant strains of human pathogens.

If upheld, the decision will mandate FDA to follow through with drug company hearings that it must conduct in order to determine whether these drugs are indeed a threat to human health. If the antibiotics are found to be dangerous to humans, FDA must see that they are withdrawn from the market for use in animal feed.

Meanwhile, the Animal Health Institute supports FDA's appeal, saying the agency is taking a swifter approach to changing livestock feeding practices.

"We remain focused on FDA's stakeholder process to phase in veterinary oversight and phase out production uses of medically important antibiotics in food animals," said Ron Phillips, AHI's vice president for Legislative and Public Affairs.

"The process that FDA is using is both more comprehensive and faster than what NRDC has asked the court to enforce," he said. "The court case is an unfortunate diversion of FDA resources and attention from their efforts to implement these significant changes."

If upheld, the decision will mandate FDA to follow through with drug company hearings that it must conduct in order to determine whether these drugs are indeed a threat to human health. If the antibiotics are found to be dangerous to humans, FDA must see that they are withdrawn from the market for use in animal feed.

According to the Union for Concerned Scientists, 70 percent of antibiotics distributed in the United States are used to promote growth or to prevent the spread of disease among animals living in crowded or unsanitary conditions. Just 10 percent of these drugs are used to treat sick animals, and the remaining 20 percent go to humans.

Tetracycline and penicillin are commonly used to promote growth in chicken, turkeys and pigs. The former is also given to cattle and sheep as a growth agent.

In 2010, over 12 million pounds of tetracycline were given to animals, compared to the 100,000 pounds sold for human use. That year almost 2 million pounds of penicillin went to livestock while 1.5 million pounds were given to humans.
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Publication:The Food & Fiber Letter
Date:Jun 11, 2012
Words:521
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