In a major shift of national food policy, the Food and Drug Administration is phasing out the non-medical use of antibiotics on farm animals in an effort to combat growing human resistance to the crucial drugs.
The plan, announced Wednesday, would push livestock and poultry producers to limit their use of antibiotics to treating sick animals, and to stop using the drugs to promote faster growth.
"We believe this is a major step forward," said Michael Taylor, the FDA's deputy commissioner for foods and veterinary medicine.
Farms consume about 80% of the nation's antibiotics supply. Such frequent use has come at a price: Antibiotic-resistant superbugs are on the rise. More than 2 million people in the U.S. now contract drug-resistant infections annually, resulting in 23,000 deaths, according to the U.S. Centers for Disease Control and Prevention.
An outbreak of antibiotic-resistant salmonella linked to Foster Farms chicken from plants in central California sickened nearly 400 people this year; about 40% were hospitalized.
Health experts say reversing the national trend will require sweeping changes in U.S. farm practices — a shift that could alter the way meat is raised in the U.S. and potentially raise production costs.
But experts said the changes are necessary to protect human health.
"We're heading into a world where antibiotics aren't working," said Laura Rogers, director for the campaign on Human Health and Industrial Farming for the Pew Charitable Trusts, who supported the FDA proposal. "The new normal needs to be one where antibiotics are used as a last choice for human medicine and animal agriculture."
The FDA plan unveiled Wednesday would finalize a strategy that requires voluntary cooperation from the drug industry.
The more than two dozen manufacturers that supply antibiotics to the meat industry are being asked to remove growth promotion claims on products that are similar to drugs used on humans. Known as medically important antimicrobials, they include popular drugs such as penicillin and tetracycline.
Drugs that have no such equivalents would still be permitted to promote growth in animals. Health experts say these drugs aren't linked to antibiotic resistance in people.
Critics in Congress as well as the National Resources Defense Council, based in New York, worry that drug companies won't fully comply with the proposal, given that it's not a mandate. But the FDA defended its voluntary approach, saying a ban on certain antibiotics would have resulted in exceedingly costly and lengthy litigation.
"The FDA is leveraging the cooperation of the pharmaceutical industry to voluntarily make these changes because we believe this approach is the fastest way to achieve our goal," said the FDA's Taylor. "Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort."
In a corresponding move, the FDA would also require livestock and poultry producers to get prescriptions to use medically important antibiotics on food animals. That puts the onus on veterinarians to evaluate individual farms to determine whether drugs are medically necessary, including as a preventive measure for disease.
"Right now farmers can just go down to the local feed shop and buy a bag of antibiotics and feed it without consulting with a veterinarian," said Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, based in Washington. "So we are hopeful there will be some improvements just by getting the vets involved."
The hope is that veterinarians will prescribe antibiotics based on what's best for the animals. But the reality is that many depend on farmers and meat producers for their livelihoods.
"Now the focus is on ethical behavior," Smith DeWaal said. "That's something the FDA really needs to take a hard look at."
Taylor said the FDA has already received commitments from two major drug producers, former Pfizer subsidiary Zoetis and Elanco, which is owned by Eli Lilly & Co.
All drug companies will have three months to notify the FDA if they agree to the plan. The agency said it would then reveal how many companies had volunteered to comply. The proposed rule is open for public comment for 90 days starting Thursday.
The Animal Health Institute, which represents drug makers, joined the American Meat Institute, the National Chicken Council and the National Pork Producers Council in support of the FDA's move. The Animal Health Institute said it would help dispel the notion that the meat industry uses antibiotics widely and irresponsibly.
"The vast majority is for disease control, prevention or treatment," said Richard Carnevale, vice president for regulatory, scientific and international affairs at the Animal Health Institute.
The FDA has been trying since the late 1970s to regulate agricultural use of antibiotics more stringently but has run into political and corporate resistance.
That's why proponents of stronger control were disappointed the FDA didn't propose stricter rules.
"The FDA's voluntary guidance is an inadequate response to the overuse of antibiotics on the farm with no mechanism for enforcement and no metric for success," said Rep. Louise Slaughter (D-N.Y.). "Sadly, this guidance is the biggest step the FDA has taken in a generation to combat the overuse of antibiotics in corporate agriculture, and it falls woefully short of what is needed to address a public health crisis."
The meat industry has had years to anticipate growing consumer demand for antibiotic-free products, which are now staples in some supermarkets. Major restaurant chains such as McDonald's and KFC also won't use meat treated with growth-promoting antibiotics linked to human medicine, the FDA said.
As the plan rolls out, meat producers will have to adjust to the new rules.
Liz Wagstrom, a veterinarian for the National Pork Producers Council, said hog farmers could expect to lose some production efficiency as pigs would probably struggle to reach their full weight.
She pointed to the experience of Denmark, which banned the use of antibiotics to promote growth more than a decade ago. There, hog farmers struggled to contain illness in herds and found it cost about $4 more to raise an individual pig to market weight. She did not say what percentage of the total cost that represented.
The National Chicken Council said there would be little effect on the nation's poultry supply and prices for consumers.
"Antibiotics are not always used in raising chickens; rather, they are administered only when needed and on those occasions, they are used judiciously under the care of a veterinarian," the group said in a statement. "For those antibiotics that are FDA-approved for use in raising chickens, the majority of them are not used in human medicine and therefore do not represent any threat of creating resistance in humans."