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Animal Drug Guidelines Proposed

Wed Sep 11, 2002

By EMILY GERSEMA, Associated Press Writer

WASHINGTON (AP) - Federal regulators are proposing guidelines to evaluate the safety of animal drugs amid concerns that the pharmaceuticals can end up in the food supply, enabling bacteria that can sicken humans to become resistant to drug treatment.

The Food and Drug Administration released the proposal Wednesday. It outlines strategies that manufacturers of animal drugs could use to determine if their new pharmaceuticals would contribute to the spread of resistant bacteria.

As more bacteria become immune to leading antibiotics, federal scientists are examining factors that may contribute to the problem, including the use of antibiotics on farm animals.

Many of the drugs fed to animals, such as penicillin, are also used to treat human illnesses.

The FDA said in the proposal that it believes humans are most likely exposed to resistant bacteria through food made from animals. Environmental groups, including Environmental Defense, said the agency is acknowledging that animal antibiotics are overused and are a health risk.

Larry Bachorik, an FDA spokesman, said the agency isn't making conclusions. It just wants to assess whether using drugs on farm animals is a health risk to humans, he said.

Environmental and health groups have criticized farmers for using antibiotics in animal feed when the animals aren't sick. The animal drug industry argues that feeding the antibiotics to farm animals actually makes food safer.

Karen Florini, a spokeswoman for Keep Antibiotics Working, said the draft proposal is a sign that federal regulators are recognizing antibiotics are overused in livestock farming. But she said the agency is failing to address the problem that farmers are using large quantities of the drugs.

"The elephant in the room is the vast quantity of antibiotics already being administered to farm animals," said Florini, who also works for Environmental Defense.

But the Animal Health Institute, a group representing drug manufacturers, said the draft merely provides a framework for manufacturers to use when identifying the risks involved with new drugs.

"The concept of risk assessment is a far better tool than legislative bans, which is what some groups have proposed," said Ronald Phillips, a spokesman for the group.

Sen. Edward Kennedy, D-Mass., and Rep. Sherrod Brown, D-Ohio, have proposed legislation that would restrict the use of some antibiotics for animal use. Florini said the proposal will probably be discussed next year.

The FDA is seeking comments from the public on its proposed guidelines.

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