An Epidemic 37 Years in the Making

Despite the potential harms of using antibiotics in livestock feed, regulators have taken little meaningful action to stop the practice.

The U.S. Food and Drug Administration (FDA) is the federal agency responsible for, among other duties, overseeing the safety of food, medications, and veterinary services.

At the intersection of those three industries lies the evolution of antibiotic-resistant bacteria. These bacterial “superbugs” increasingly appear in hospitals, on farms, and on raw meat at your grocery store, sickening more than two million people a year and killing 23,000.


Currently, 80 percent of the antibiotics used in the U.S.—29.9 million pounds—are given to livestock meant for your dinner table, according to the FDA. That number increases every year, and the global market for veterinary antibiotics is expected to reach $19.54 billion by 2020.

As the threat increases, the U.S. Centers for Disease Control and Prevention (CDC) have been warning citizens and the healthcare industry to avoid antibiotic misuse with judicious prescribing practices, including using antibiotics only when necessary.

Those in the agricultural and pharmaceutical industries cite a lack of evidence that the routine administration of antibiotics to animals affects human health. While antibiotics are key to human health, they are also pivotal for modern farming, in which large numbers of animals are housed in tight, sometimes unsanitary quarters, where disease is likely to spread.

“I agree there was a lack of evidence of direct animal use leading to antibiotic resistance. That was an issue before, and that was a point most of the lobbies were mentioning,” Sumanth Gandra, an infectious disease physician at the Center for Disease Dynamics, Economics & Policy (CDDEP), told Healthline. “As we get more solid evidence data, I think it will be good to fight back.”

While no single factor is solely responsible for drug-resistant bacteria, basic biology tells us that the more bacteria are exposed to antibiotics, the more chances the bugs have to develop protection against them.

To date, the food animal production industry remains excused from the same scrutiny faced by other industries.
Johns Hopkins University’s Center for a Livable Future

There is clear scientific evidence—accepted by more than 450 medical associations and public health entities—that antibiotic use in agriculture has contributed to deadly infections in humans.

People can become sick by eating meat from infected animals, using improper hygiene when handling the meat, or consuming raw produce that contains infected animal manure.

While countries like Denmark have taken action by banning routine drug use in animals reared for food, the FDA’s strategy to manage these threats is to ask pharmaceutical companies to put antibiotics under a veterinarian’s oversight.

“To date, the food animal production industry remains excused from the same scrutiny faced by other industries,” according to Johns Hopkins University’s Center for a Livable Future.

Groups like the Natural Resources Defense Council (NRDC) are actively opposing what they see as the industry and the FDA’s inaction since 1977.

“We’re seeing the tipping point in the debate on whether or not there’s a health risk here,” Avinash Kar, a health attorney with the NRDC who has brought litigation against the FDA, told Healthline. “I think we’re on the other side of that now and the real question is where’s the political will to actually solve the problem that 99 percent of us agree exists. There’s still some holdouts on the industry side.”

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The Continuing (and Controversial) Practice of Adding Antibiotics to Animal Feed

Farmers have been allowed to use antibiotics for growth promotion since the 1950s.

During World War II, Congress, concerned about the efficacy of antibiotics for soldiers, gave the FDA regulatory authority over them, but allowed the agency to waive certain requirements if the drugs were proven safe. This allowed farmers to use antibiotics for nontherapeutic reasons, such as growth promotion.

In the 1950s, the FDA approved the use of penicillin and tetracyclines to “stimulate growth and promote feed efficiency in food-producing animals” to help stabilize the country’s food supply. This led to the large-scale distribution of antibiotics to cows, pigs, poultry, and other animals to help bulk them up before slaughter.

While antibiotics are no longer approved for growth promotion, farmers still routinely feed animals small doses of antibiotics for “disease prevention” on large factory farms. It may have a new name, but the practice remains the same: low doses of antibiotics routinely given to animals in their feed.

Many of the drugs given to animals, such as penicillin and tetracyclines, are the same ones used to fight infections in humans.

As early as 1955, researchers began warning of potential problems with widespread antibiotic use, including common bacteria becoming resistant to the drugs. In 1969, the Swann Report stated that antibiotics shouldn’t be used for growth promotion in either animals or humans.

By the mid-1970s, the FDA had become concerned with the safety of antibiotic use in animal feed. It threatened to withdraw its approval of all drugs for nontherapeutic use in animals unless the interested parties could prove the drugs were safe.

At the time, animal antibiotics was a $270 million industry.


In 1977, the FDA’s own National Advisory Food and Drug Committee recommended that the agency withdraw approval for nontherapeutic uses of penicillin and all uses of tetracyclines. No one could prove that their continued use was safe and, under the law, the FDA was compelled to act on the findings.

Donald Kennedy, then commissioner of the FDA, granted requests from drug companies, agricultural organizations, and other interested parties for a public hearing on the subject of withdrawing the drugs from use in animals meant for human consumption.

There's no question that routinely administering non-therapeutic doses of antibiotics to food animals contributes to antibiotic resistance.
Donald Kennedy, former commissioner, U.S. Food and Drug Administration

Members of Congress intervened, demanding more research be done on the issue. The public hearings never happened, and the drugs remained on the market.

The FDA took no further action, even though three reports the agency had commissioned on the matter were unable to show that antibiotic use in livestock was safe.

Since then, Kennedy, now a professor emeritus at Stanford University, has joined forces with other scientists to campaign against the use of antibiotics in agriculture because, he says, it puts human lives at risk and drives up healthcare costs.

“There's no question that routinely administering non-therapeutic doses of antibiotics to food animals contributes to antibiotic resistance,” he told The Guardian in 2012.

The FDA has offered numerous recommendations to the farming industry over the years, but adherence is voluntary, not mandated by law. Its latest measure, Guidance 213, was immediately subject to harsh criticism when the FDA announced it late last year.

Georgetown University law professor Lisa Heinzerling, who has examined four decades of FDA recommendations on antibiotic use in agriculture, called the agency’s polices “lame” and “feeble.”

“The FDA’s decision to depend on voluntary action by drug companies and to continue to allow routine uses of antibiotics in whole herds and flocks of animals in order to prevent infections brought on by stressful conditions leave gaping holes in the protection the agency purports to provide,” she wrote in an essay.

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FDA Issues Voluntary Guidance on 685 Approved Drugs

Agency documents reveal many drugs don't meet safety standards.

Guidance 213 asks drug companies to voluntarily revise how they label the antibiotics they develop for use in agriculture. This includes labeling the drugs only for uses supported by science, and puts all antibiotic drugs, including those administered in feed and water, under veterinary oversight. The guidance takes effect in December 2016.

As of March of this year, 25 of the 26 affected companies in the animal pharmaceutical industry have submitted written statements to the FDA saying they will comply with Guidance 213.


Currently, about 685 drugs, not all of them antimicrobials, have been approved by the FDA for use in animal feed, according to the latest report from Johns Hopkins’ Center for a Livable Future on industrial food animal production.

The report, issued every five years, concluded that the United States lacks transparency in the agricultural industry, and that the FDA’s voluntary guidance has produced limited success.

“Despite the sizable body of literature supportive of a decision to eliminate antimicrobial use outside the context of veterinarian-diagnosed disease, little progress has been made to change patterns of use,” the report states. “While some meager success has been achieved … the voluntary approach preferred by the FDA and the lack of willingness by the industry to alter its behavior suggest that meaningful change is unlikely in the near future.”

The FDA, from 2001 to 2010, independently reviewed the safety of 30 penicillin and tetracycline antibiotic feed additives approved for “growth promotion or to prevent disease in typically crowded, often unsanitary conditions in livestock and poultry,” according to an NRDC investigation earlier this year using documents obtained in federal court.

Of the 30 drugs, 18 were deemed high risk for potentially exposing humans to drug-resistant bacteria through the food chain. As for the other drugs, scientists lacked adequate data to make a determination.

While some meager success has been achieved … the voluntary approach preferred by the FDA and the lack of willingness by the industry to alter its behavior suggest that meaningful change is unlikely in the near future.
Johns Hopkins University’s Center for a Livable Future

The FDA found that none of the additives would likely be approved for nontherapeutic use in livestock if they were submitted under current FDA guidelines. At least 26 of them wouldn’t meet the standards set in 1973, the NRDC investigation found.

A separate Johns Hopkins study, published in 2012, found that feather meal, a poultry byproduct fed to poultry, pigs, cattle, and fish, contained fluoroquinolones—an important class of antibiotics used to treat humans—which were banned from use in poultry in 2005.

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How Does Voluntary Guidance Affect the Agriculture Industry?

Many in the ranching industry are unconcerned about new FDA measures.

William Flynn, deputy director for science policy with the FDA's Center for Veterinary Medicine, said that the FDA opted to make Guidance 213 voluntary because “it is the fastest, most efficient way to make these changes.”

Some in the agriculture industry say that the voluntary guidelines won’t have much impact because the majority of farmers already follow good stewardship practices.

Tom Talbot, a veterinarian, California cattle rancher, and past president of the National Cattlemen’s Beef Association—the largest representative body for beef producers—said that Guidance 213 won’t affect the average farmer because the number who use antibiotics in feed is “extremely small.” After its enactment, he said, he called his contacts and found no hesitation from agribusinesses to comply.

To Talbot, the term “factory farm”—a large-scale operation that raises animals in tight quarters—is a four-letter word because, he says, the average herd of cattle in the U.S. contains only 44 animals.


“It’s not widespread practice to feed antibiotics to animals to promote growth. It happens, but it’s not widespread,” Talbot said. “In reality, I don’t think it’s going to have a big impact on the majority of farming. If it does affect [a farmer], it’s probably good it will affect him. There’s always the outliers.”

As recently as 2011, the Department of Agriculture’s Animal and Plant Health Inspection Service found that more than 80 percent of swine farms, cattle feedlots, and sheep farms routinely deliver antimicrobial drugs in feed and water for growth or health purposes.

“The use of antibiotics in feed and water has remained consistent across study years,” the report states. “Few feedlots tested any cattle for antibiotic residues prior to shipping for slaughter.”

The majority of meat consumed in the U.S. comes from large-scale farms, with more than 2,100 feedlots that can accommodate up to 1,000 animals, according to Tyson Foods investor information. Tyson raises poultry, beef, and pork.

It’s not widespread practice to feed antibiotics to animals to promote growth. It happens, but it’s not widespread.
Tom Talbott, past president, National Cattlemen’s Beef Association

According to the Environmental Protection Agency, the head count for cows meant for human consumption remains steady at 11.3 million, with all beef cattle totaling about 30 million animals spread out over one million farms and ranches. Cattle production in the U.S. has steadily increased since the 1960s.

Hogs are more often raised in larger, more efficient operations, with fewer smaller farms producing pigs for profit. The U.S. remains the largest pork producer, consumer, and exporter in the world.

To keep up with increased demand, chicken farming has moved from backyard settings to large-scale farms. Poultry production is a vertically integrated industry. Using engineered feed—most of which contains low doses of antibiotics—at all points in the process, a farmer can get a chicken to reach market weight in just 46 days.

Feed is the most expensive part of raising hogs and cattle—as much as 80 percent of the cost. So the long-standing practice of using antibiotics in feed has helped increase profits, because the drugs help promote weight gain without increasing the amount of food the animal eats.

A farmer, like any businessperson, is concerned about the bottom line. Instead of paying up to $20 per head of cattle for antibiotics, using vaccines, which cost as little as $1, along with good breeding and nutrition, are better for the farmer, Talbot said.

The loss of antibiotics due to antimicrobial resistance and/or regulatory restrictions is a critical issue for the animal health community.
Cyril Gay, senior national program leader, Agricultural Research Service

“The less antibiotics we can use, the better,” he said.

But groups like the Animal Health Institute, the trade association of companies that produce antibiotics for animals, continue to deny scientific evidence that their practices have an impact on human health.

Cyril Gay, senior national program leader for the Agricultural Research Service (ARS), told Healthline he agrees with those in the industry who believe there “is significant doubt that the use of antibiotics in animals meant for human consumption contribute to antibiotic resistance.”

That’s why the ARS, the research arm of the U.S. Department of Agriculture (USDA), which regulates how farms operate, conducts research on alternatives to antibiotics that are less likely to create antimicrobial resistance.

“Like human medicine, the veterinary profession needs vaccines and drugs to prevent and treat animal diseases,” Gay said. “The loss of antibiotics due to antimicrobial resistance and/or regulatory restrictions is a critical issue for the animal health community.”

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Forcing the FDA’s Hand in Court

Those concerned about antibiotic use in livestock are suing the FDA to force it into action.

The NRDC has brought legal action against the FDA, imploring the organization to act on its own 1977 findings of potential dangers in routine agricultural antibiotic use.

In May 2011, the NRDC, the Center for Science in the Public Interest, the Food Animal Concerns Trust, Public Citizen Inc., and the Union of Concerned Scientists filed a lawsuit in federal court in an attempt to force the FDA to do what it is legally required to do: force drug manufacturers to prove that their products are safe.


Besides the FDA, the lawsuit names FDA Commissioner Margaret Hamburg; the Center for Veterinary Medicine and its director, Bernadette Dunham; the U.S. Department of Health and Human Services and its former secretary Kathleen Sebelius as defendants.

When asked for a statement about the suit, a representative from the FDA told Healthline that the agency does not comment on ongoing litigation.

“The court eventually agreed with us and directed FDA to withdraw approval of penicillin and tetracyclines in feed unless drug manufacturers approve their safety,” Kar, the NRDC attorney, said.

The FDA appealed, saying that complying with the judge’s orders would “irreparably harm” the agency by forcing it to divert its financial resources to address the issue. U.S. Magistrate Judge James C. Francis IV rejected that argument. On July 24, the U.S. Second Circuit Court of Appeals sided with the FDA, allowing the practice of routinely giving food animals antibiotics to continue.

There’s probably a lot of hardworking scientists and regulators over there, but we believe they’re under so much political pressure from these industries that they just don’t dare.
Jonathan Kaplan, food and agriculture program director, Natural Resources Defense Council

In response to the court ruling, Dr. Robert S. Lawrence, director of the Johns Hopkins Center for a Livable Future and a professor at the Johns Hopkins Bloomberg School of Public Health said, “The misuse of antibiotics in food animal production contributes to the epidemic of antibiotic resistance in our hospitals and communities. Today’s decision is deeply disappointing because it allows voluntary guidelines to take the place of decisive action in confronting one of the most important public health problems of our time.”

Jonathan Kaplan, the NRDC’s food and agriculture program director, said that the FDA’s inaction isn’t caused just by bureaucracy—it’s also due to political resistance.

“It’s not just like they’re incapable or lazy,” he said. “There’s probably a lot of hardworking scientists and regulators over there, but we believe they’re under so much political pressure from these industries that they just don’t dare.”

The next story in this series will examine consumer attitudes toward antibiotics in livestock, as well as look at businesses and countries that have stopped using antibiotics in animals for nontherapeutic reasons. Whether it has worked depends on whom you’re asking.
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