With newly proposed recommendations targeting the use of antibiotics in livestock, the federal Food and Drug Administration is asking the oft-evolving agriculture industry to adapt yet again.

The FDA’s eye is toward reducing instances of drug-resistant bacteria, which the agency says have grown into a major public health threat. The thrust of its policy is to curb the use of many antibiotics that speed the growth of animals used for meat in the U.S. and limit the drugs’ uses to preventing, controlling and treating diagnosed illnesses.

The FDA hopes that, at least in the beginning, farmers and drug companies will adopt this strategy voluntarily.

“I think this is the beginning of a process to look into what antibiotics can do or might be doing, and agriculture is on board with it, and the FDA is on board with looking at this and not trying to pull the trigger on something before its time,” said Gordon Metz, a longtime cattleman from Henry County.

Proceeding with caution means that questions about scientific interpretations, public health pressure, financial viability and environmental impacts will all likely be part of the FDA’s public comment period.

Leaning on national and international research, the FDA says that any use of antimicrobial drugs — which include antibiotics — can spur resistance in both humans and animals and that the drugs must be applied judiciously. The Centers for Disease Control and Prevention reported last year that about 23,000 people die annually because of antibiotic resistance and more than 2 million are sickened.

Estimates for treatment and related costs to the health care industry can be as high as $35 billion a year, the CDC said.

The FDA’s policy shift is several years in the making, and the final draft document guiding the agency’s strategy was released at the end of last year. Such guidance documents reflect a government agency’s current thinking and are not legally enforceable.

The new effort isn’t particularly surprising in agriculture, nor is it pioneering. Sweden, for example, banned food growth-promoting antimicrobials for livestock in 1986, and the European Union took significant steps in the late 1990s.

“We need to be selective about the drugs we use in animals and when we use them,” said Dr. William Flynn, deputy director for science policy at the FDA’s Center for Veterinary Medicine. “Antimicrobial resistance may not be completely preventable, but we need to do what we can to slow it down.”

Impact on agriculture

Antibiotics are frequently used in livestock and are among the drugs most commonly prescribed to humans, though often in excess, according to the CDC.

Not all antibiotics are part of the new FDA scrutiny — only ones in a medically important group that are used to treat humans and also consistently used at subtherapeutic levels in feed and water to enhance an animal’s production cycle. The production uses for certain antibiotics in beef, poultry and pork can help to promote weight gain or make animals’ food more efficient, though Flynn notes that it’s not scientifically clear how antibiotics achieve those goals.

The FDA said it recognizes that its latest measures can affect animal agriculture.

“FDA has worked closely with USDA [U.S. Department of Agriculture], animal producers and veterinarians to find ways to implement the recommendations while keeping the impact on animal health and disruption to the animal agriculture industry to a minimum,” said Juli Putnam, a media officer with the FDA.

The degree of the impact can vary throughout the state. While some point toward cost and time consequences, Bedford County, one of the top cattle-producing counties in Virginia, isn’t expected to be hit hard. The type of cattle production done there doesn’t require a significant amount of grain feed, and there are no commercial swine or poultry operations, said Scott Baker, coordinator for the county’s Virginia Cooperative Extension office.

In Bedford County, “very few producers would be using antibiotics covered by these guidelines for growth promotion or efficiency enhancement,” Baker said.

The new policy recommends that those who own the rights to market animal drugs revise the approved uses of their products and that veterinarians are given oversight of their application. If makers opt to label their drugs to be used only for sick animals, then it would be illegal to use them specifically for livestock growth no matter the dosage, according to the Federal Food, Drug and Cosmetics Act.

Metz, who’s also on the Virginia Farm Bureau Federation’s board of directors for the region stretching from Henry to Alleghany counties and over to Bedford County, said the recommendations made by the FDA are another in a lengthy chain of regulatory layers to production — something that farmers are used to weathering.

“These little things don’t really put you out of business, but they add on to the cost of the level that’s going up,” he said. “Whether it’s the cost of the equipment to do it, the cost of the labor, the cost of the fertilizer, the fuel to transport it, those are just levels, and individual ones shouldn’t put you out of business, but it will make some difference on the bottom line.”

Metz doesn’t use feed-additive antibiotics on his farm, but he said that for farmers who are used to using them, it could easily take weeks longer for livestock to reach optimal weight without the antibiotics, at an increased expense of both time and feed.

Farmers have long had to be responsive to the science, politics and public perception of the industry, while trying to entrench themselves as good stewards of the land and the U.S. food supply.

“We in the farming community rely on people who have done research, rely on people who look into issues,” Metz said. “Farmers overall have had to rely on those people we buy the products from and those people that govern and test products.”

Documents presented by the FDA show that the scientific framework for its decision goes back more than 40 years and includes national and international studies and task force recommendations, nearly a dozen of which were completed in the past five years. But the Virginia Farm Bureau challenges the conclusions reached by the FDA, arguing for skepticism until more direct evidence is presented.

“There is little, if any, credible peer-reviewed scientific evidence that the use of subtherapeutic antibiotics in animal feed and water is linked to antibiotic resistance in humans,” said Spencer Neale, director of the Commodity Marketing Department at Virginia Farm Bureau. “While we all have concerns over antibiotic resistance in humans, decisions to address the issue need to be based on sound scientific evidence versus being driven by public opinion.”

He stressed that the agriculture industry strongly cares about the well-being of animals and wants to deliver a healthful product to consumers.

‘Collaborative approach’

The latest data available, from 2011, show that the sales of antimicrobial drugs for animals are close to 30 million pounds in the U.S. — and rising. But, Neale said, that is for a nation that has close to 100 million head of cattle, more than 60 million hogs and several billion chickens and turkeys. He added, “by no means do all food animal producers use subtherapeutic antibiotics in their feed rations.”

Metz said that antibiotics as feed additives are most commonly seen on farms that have large confined populations of livestock, such as cattle feedlots.

The FDA has said it believes that the change in policy is best implemented by collaborating with stakeholders, including pharmaceutical companies and veterinarians. Stiffer regulatory action, Putnam said, would be more disruptive to the animal health and agriculture industries and would drain significantly more resources and time.

“This collaborative approach,” she said, “is the quickest way to achieve the greatest degree of public health protection.”

Monitoring and evaluation are among the most significant challenges on the horizon. Animal pharmaceutical companies are being asked in the coming months to decide whether they will adopt the recommendations to remove previously approved production uses from their products and revise how the products are marketed, to include veterinary oversight.

“The concern among livestock and poultry producers is how will FDA determine if its efforts have been successful, and is this just a first step in moving to more mandatory restrictions, which may in fact come with cost to the health and well-being of the animals affected,” said Neale, with Virginia Farm Bureau. “The ag community understands the significance of antibiotic resistance in humans and will lead the charge in making any necessary changes if and when the science proves such changes will make a difference.”

The FDA said it is working with the USDA and the CDC on data collection. Over the next three years, the FDA plans to scour the voluntary rollout and assess how it was implemented and how livestock and food products are affected.

After the three-year period is up, Metz said, “I think the marketplace will determine what happens.”

Online: To comment on the FDA’s guidance document, go to www.regulations.gov. The comment period closes March 12.