LEXINGTON, Ky. — Last week the U.S. Food and Drug Administration (FDA) introduced possible regulations that would change the way antibiotics are used on the farm, in the name of public health.

The agency is suggesting three steps to “promote the judicious use of medically important antibiotics in food-producing animals.” For years producers have used drugs, including antibiotics, in production to help prevent illness in animals and promote growth. Some animal feed manufacturers have included small amounts of antibiotics in their products.

The production use of antibiotics in meat animals, which is the basis for these regulations, and their prolonged use in human medicine have been considered reasons some human diseases have become resistant to certain antibiotics.

Because of that and the data that suggest it, the FDA said it “is proposing a voluntary initiative to phase in certain changes to how medically important antimicrobial drugs are labeled and used in food-producing animals. FDA is taking this action to help preserve the effectiveness of medically important antimicrobials for treating disease in humans.”

According to information from the FDA, the proposals include:

•A final guidance for industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.

 

A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control and treatment uses; and changing the marketing status to include veterinary oversight

•A draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient

The three documents were published on the Federal Register April 11. FDA Commissioner Margaret A. Hamburg, M.D. said it is critical to take action that will protect public health.

“The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective. We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available,” she said.

With differing opinions from industry experts, implementing the recommendations may prove to be a challenge.

Dr. Barry Hays, who serves as associate veterinarian and teacher at the Locust Trace Agri-Science Farm in Lexington, Ky., said the use of growth hormones in animals has slowed significantly over the years, and most farmers use antibiotics only when needed. But they have the opportunity to do so without the advice of a veterinarian, buying such drugs at feed stores, for the most part.

“Our drug companies at one time allowed veterinarians to regulate a lot of the drugs that were used with meat-producing animals and dairies, but the drug companies found they could make a whole lot more money if they took it out of our hands and put it in the feed stores,” he said. “It was an economic thing and we’ve seen that over time with a lot of the products.”

Hays added much of the use of antibiotics in feed comes as an illness preventative, especially in the poultry industry where one sick animal could infect hundreds of birds at one time.

He thinks the FDA move is a way to help regulate use and not stop it by any means, because illness in herds can devastate producers and those farmers need the ability to take care of their animals.

“What the FDA is trying to do is regulate this where it is not so widespread, and have some control over it,” he said.

Hays pointed out many areas of Kentucky are underserved by large-animal vets and farmers have become accustomed to, and quite good at, recognizing when their animals need antibiotics and administering those drugs. The ability to buy them at their local feed stores has helped many producers in these rural areas. “There’s a lot that’s going to occur before (these regulations) become law, I’m sure of it,” Hays said.

Agricultural organizations are beginning to weigh in on the news. The Animal Health Institute said: “The veterinarian is critically important in animal care decisions and, ultimately, in protecting food safety and human health. We strongly support responsible use of antibiotic medicines and the involvement of a veterinarian whenever antibiotics are administered to food-producing animals.”

Tom Talbot, a beef producer, large-animal vet and chair of the National Cattlemen’s Beef Assoc. (NCBA) Cattle Health and Well-Being Committee, issued a statement saying, “The goal of giving veterinarians greater oversight of antibiotic use in food animals is commendable, but cattlemen are concerned with the feasibility of implementing the veterinary feed directives given practical hurdles, including a current shortage of veterinarians in many rural areas throughout the country and the increased record-keeping burden it could have on the day-to-day requirements veterinarians now face.

“Cattle producers have a strong track record of working with veterinarians in the prudent and appropriate use of antibiotics and other herd health tools.”

The National Pork Producers Council said, “The loss of and restricted access to products expected with implementation of the U.S. Food and Drug Administration’s guidance on the use of antibiotics in livestock and poultry production likely will disproportionately affect small producers.”

The livestock industry in Kentucky has moved to the forefront of the state’s ag economy. Sam Faulkner, a cattle producer in Bourbon County and manager of the Paris Stockyard, said it is hard to estimate how many calves would be lost if farmers could not administer antibiotics themselves – not to mention the increased cost. “Just the cost of it, we couldn’t stand the price. If we buy our antibiotics from a veterinarian, it would cost 25 to 50 percent higher than we can buy them wholesale,” he said.

He said livestock producers already have to get prescriptions from vets for many antibiotics excluding a few older-type drugs. They may still purchase them away from the vet’s office, but the oversight is there. Faulkner also said most producers have been through proper training to give these injections and that at least for the cattle business, most are good stewards and are not overusing them.

“We are not out there to do anything wrong. We want to stay within guidelines,” he said. “We are definitely regulated enough, and we are getting to the point that a lot of people are going to quit if this goes into effect. I would have to quit. I cannot precondition cattle if I could not administer my own antibiotics.”

The proposals are open to public comment. For details, call 888-463-6332 or visit www.fda.gov/AboutFDA/ContactFDA