The Food and Drug Administration said Wednesday it would begin phasing out the use of antibiotics in animal feed that make animals grow faster on less food, while phasing in requirements for veterinary oversight of the remaining uses of such drugs.
The agency said that it was giving drug companies that sell antibiotics for animal feed 90 days to voluntarily rewrite the labels on those drugs. The new labels will say that the antibiotics and antimicrobials can only be used to treat actual illnesses in animals under the supervision of a veterinarian.
By volume, three times more antibiotics are sold for use in animals than to treat humans, according to the World Health Organization.
Antibiotics and antimicrobials are routinely mixed into the feed of animals such as cows, pigs, chickens and turkeys to make them grow faster and put on more weight with less feed.
No one actually knows why antibiotics and antimicrobials made animals grow faster, said William Flynn, deputy director for science policy with the FDA's Center for Veterinary Medicine.
Public health officials have long decried the practice. "It is inappropriate to routinely feed antibiotics to healthy animals just because they live in overcrowded conditions that are conducive to the spread of disease," said Gail Hansen, with The Pew Charitable Trusts' human health and industrial farming campaign.
The Centers for Disease Control and Prevention issued a report in September that said "antibiotics should be used in food-producing animals only under veterinary oversight and only to manage and treat infectious diseases, not to promote growth."
Decades of scientific research has linked the overuse and misuse of antibiotics in food animals to rising antibiotic resistance in human pathogens. It is a real and growing concern for doctors, said Robert Lawrence, a professor with the Johns Hopkins Bloomberg School of Public Health in Baltimore.
"An infection that is now considered relatively easy to treat could once again prove fatal should antibiotics continue to be misused in food animal production and exacerbate this growing public health crisis," Lawrence said.
The new FDA guidelines are meant to end the use of drugs that are important to treating humans in animal feed. Once that label change is made voluntarily on a given drug "it is a violation of federal law" to use that drug in any other way, said Mike Taylor, deputy commissioner for foods and veterinary medicine at the FDA.
"We believe that this is major step forward in helping to ensure that important antibiotics maintain their effectiveness for the future," Taylor said.
This marks a major shift from the current situation, when animal producers "can go to the local feed store and buy these products over the counter and there's no veterinary oversight at all," said Taylor. Under the guidelines, the oversight of a veterinarian will be required to prescribe antibiotics that are used on humans to treat sick animals.
The two largest producers of these drugs, Zoetis in Florham Park, N.J., and Elanco in Indianapolis, have agreed to change their labels, Taylor said. "We expect to see other companies come on board," over the next 90 says, he said.
Drugs that will be affected include tetracyclines, penicillin and macrolides such as azithromycin, Flynn said.
Classes of drugs that are not used to treat human illness will continue to be available to animal producers to add to feed to increase growth, said Flynn.
After three years, the FDA will evaluate how the voluntary label changes have gone and whether further action is warranted, Taylor said.
The agency chose to do this as a voluntary request because "it avoids the legalistic, product-by-product regulatory proceedings that would take years to complete," Taylor said.
The voluntary aspect of the plan troubles Caroline Smith DeWaal, food safety director with the Center for Science in the Public Interest in Washington, D.C.
"It requires the drug companies who profit from sales of their drugs to initiate the process," she said. "The good news is that the agency has pledged to evaluate levels of compliance and inform the public after 90 days if the drug industry is cooperating with the relabeling effort."
Many groups that have long worked to slow antibiotic resistance were cautiously hopeful. "We commend FDA for taking the first steps since 1977 to broadly reduce antibiotic overuse in livestock," said Laura Rogers, director of The Pew Charitable Trusts' human health and industrial farming campaign. "There is more work to do, but this is a promising start - especially after decades of inaction."
"It's a good first step down the path toward ending antibiotic overuse in animal agriculture," said Jean Halloran, Director of Food Policy Initiatives for Consumers Union.
Rep. Louise Slaughter, D-New York, the only microbiologist in Congress, called the regulation inadequate.
"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 Keep Antibiotics Working Coalition was happy to see that FDA has released the long-awaited guidelines but "our fear, however, is that there will be no reduction in antibiotic use as companies will either ignore the plan altogether or simply switch from using antibiotics for routine growth promotion to using the same antibiotics for routine disease prevention," said the group's Steven Roach.
The American Meat Institute, an industry trade group, supported the change. It is "consistent with protecting both animal and public health, ensuring the ability to medically treat animals, and maintaining the highest standard of animal welfare practices," said AMI's chief scientist Betsy Booren.
The market is already moving in this direction, said Taylor. "There are significant animal producers in the animal product who have on their own initiative stopped using these products for production uses."
In addition, major food retail chains including McDonalds and Kentucky Fried Chicken now have publicly said that they won't buy meat raised using these medically important growth-promoting antibiotics, he said.
It's unclear if the shift will result in higher prices for meat, said Thomas Myers, chief policy officer with the U.S. Department of Agriculture's animal and plant health inspection service. Economists with the agency's Economic Research Service are looking at possible price changes as the new rules are phased in over the next three years, he said.