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Putting animals at risk

Proposed FDA regulations would eliminate nearly all drugs for livestock

Someday, when a cattleman or pork producer goes to the refrigerator for a bottle of antibiotics, the shelf will be bare. New regulations proposed by the Food and Drug Administration (FDA) could eliminate nearly all antimicrobials now on the market for cattle and hogs. (Antimicrobials include most antibiotics plus other drugs like sulfa.)

No new products will replace these, either. Phar-maceutical companies won't research new antimicrobials for animals because the risk is too great that the products will never be approved for use.

What may be the ultimate outcome of this? Ironically, an unsafe food supply. FDA wants these stricter regulations to keep humans safe. It fears that the use of antimicrobials in livestock will trigger a resistant bacteria that may infect humans.

But livestock industry experts believe that the regulations go too far. They claim that producers won't have many drugs to treat their sick animals. This, in turn, means that sick animals could enter the food supply.

The resistance debate. The debate over antibiotic resistance is not new. Since the early 1970s, FDA has brought up the issue every 5 to 10 years, usually with little resolution.

This time may be different. The Animal Health Institute (AHI), representing manufacturers of animal health products, is braced for a big battle. Representatives of the institute testified before the FDA Veterinary Medicine Advisory Committee about their concerns about the proposed rules. These rules have the potential to "really restrict the availability of those products," says John Keeling, AHI vice president. Such an action will "put animals and producers at risk, with no offsetting improvement in human health," Keeling asserts.

FDA's new tough rules create a framework for evaluating and ap-proving antimicrobial drugs for food-producing animals. The approval process will be stricter and considerably more expensive with on-farm trials required.

Drugs will be categorized according to importance to human health. Category 1 drugs are most important to human health, and these will not be available for use in animals.

"I don't know if there will be any antimicrobials that will not be under Category 1," reports Paul Sundberg, DVM, National Pork Producers Council. "Those are the restricted drugs and we won't have them. At this point, we don't think there is anything that will be available."

Fickle bugs. The battle over anti-microbials comes back to the fickleness of pathogens. When antimicrobials are introduced to pathogens, the pathogens begin to react, often developing different levels of resistance. But not always. Sometimes, the pathogens become more susceptible to a drug. But, Keeling notes, "antibiotic resistance is a fact of life."

The disputed question is, How much danger does the drug resistance in animals pose to human life? FDA believes a pathogen in animals will become resistant to an antimicrobial. Then people will eat food with the resistant pathogen, making them ill. Unfortunately, no antimicrobials will exist to treat the pathogen.

This scenario has never occurred. The Center for Disease Control has never documented a case where an animal drug caused a resistant food-borne pathogen to lead to a human death. Meanwhile, plenty of food-borne pathogens (not originating in animals) do cause deaths, between 2,000 and 9,000 a year. But FDA wants to make sure one caused by an animal drug never happens.

The livestock groups and AHI say they don't want a public health problem either. They just want FDA to base its regulations on science and good data, both of which, they claim, are missing in the proposed rules. Instead, they want to accurately assess the risk and then make rules to handle it.

"The bottom line here is food safety and public health," Sundberg says. "With our long history of safe drug use, we aren't ready to accept that we are the cause of all the evils of resistance. That's why we need to measure what the real risk is."

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