WASHINGTON – Sometimes Dar Geiss needs antibiotics to treat the cattle on his ranch in central Minnesota. Soon, he will have to go through a more encumbered procedure to get those drugs.
A new Food and Drug Administration program aimed at lowering the growth of antibiotic-resistant bacteria dramatically changes the application and delivery of dozens of infection-fighting drugs to cattle, hog, turkey and chicken producers across the country.
The new policy no longer allows certain antibiotics to be used as growth supplements in animal feed and drinking water — or to be sold over the counter. Instead, many antibiotics that are medically important to humans as well as animals will be relabeled for therapeutic use only, and their distribution will be overseen by veterinarians.
The changes follow years of controversy and debate and is expected to affect livestock producers across Minnesota who collectively bring tens of millions of animals to market each year. Minnesota is the nation's largest turkey producer and one of the top five states for hog production.
"Some products may or may not stay available for use," Dave Preisler, executive director of the Minnesota Pork Producers Association. "You will not be able to go to Fleet Farm and purchase products as you can now."
The use of antibiotic feed to increase animal growth "is not something we practice every day," said Geiss, president of the Minnesota State Cattlemen's Association. But, he added, the purchase and use of antibiotics under the new program will be "a big switch from nutrition companies to vet oversight."
FDA officials say the changes are part of an ongoing effort to curb an increase in bacteria that can withstand antibiotic treatment and cause people to remain sick. The FDA has asked makers of animal pharmaceuticals to participate voluntarily for now, but could make regulations mandatory if too few animal drugmakers participate.
"Many factors contribute to the emerging resistance in bacteria," said Dr. Bill Flynn, an FDA veterinarian. "They include all uses in animals and humans."
Flynn cannot say precisely how much the overuse of antibiotics in animals contributes to what many believe is a public health problem. But he said that giving antibiotics merely to promote growth and production in animals "don't represent judicious uses." So feed treated with certain antibiotics that are important human health will no longer be sold over the counter and using them solely to enhance animal size will be prohibited.
Not all animal antibiotics fall under the new program, Flynn said. One class, called ionophores, is used primarily to improve animal growth, Flynn said. But because it has no human use, it can still be placed in feed used to make animals grow larger.
A 3-year phase-in
The Animal Health Institute (AHI), a trade group representing companies that make 80 percent of animal drugs, has encouraged its members to participate in the voluntary relabeling of antibiotics targeted by the FDA. The new labels would not mention growth promotion and their distribution would require involvement of veterinarians.
"We have never felt the use of antibiotics in feed has been a public health issue," said Dr. Rich Carnevale, the vet who directs the institute's regulatory affairs. "But perception is reality."
Carnevale said no one knows exactly how often animal producers use antibiotics strictly to promote animal growth, but AHI polling of its members puts the market share at an estimated 15 percent of the 29 million pounds of animal antibiotics distributed each year.
Animal drugmakers have 90 days to say if they will voluntarily apply to FDA to relabel their products to meet the conditions of the new program. The agency will review and decide whether to grant relabeling requests. Drugmakers must demonstrate a therapeutic use for their products to get them relabeled. The program calls for a three-year phase-in.
"There is going to be administrative expense," Carnevale said. "There are a number of applications involved with individual drugs and combinations of drugs. There is quite a bit of work to do."
On the producer and veterinary end of things, logistical challenges loom. The pork association's Preisler says some small hog farmers don't have veterinarians to turn to for prescriptions.
Steve Olsen, who directs the Minnesota Turkey Growers Association, says a shortage of food production vets stretches across the country.
"Central Minnesota has been identified by the U.S. Department of Agriculture as a shortage area for poultry vets," Olsen said.
The FDA's Flynn concedes that the logistics of connecting with vets to write antibiotic prescriptions or otherwise approve antibiotic distributions is a "potential practical problem." He says his agency is working with the U.S. Department of Agriculture to try to find solutions.
The Minnesota Department of Agriculture is not yet sure how application of the new antibiotic program will affect its current job inspecting 247 feed mills in the state that mix medications with their products.
Dr. Heidi Kassenborg, a vet who directs the state's dairy and food inspection, expects an increased workload because the only two drugs now require veterinary oversight, while the new program adds a half-dozen classes of drugs with several products in each class.
"We'll try to do education first," Kassenborg said of the state's efforts to reach out to the agricultural community. "Our goal is compliance, not enforcement."