The Food and Drug Administration (FDA) said Wednesday that it was beginning to phase out the use of some antibiotics in animals raised for meat, a major policy shift that could have far-reaching implications for industrial farming and human health.
The change, which will take effect over the next three years, is the first serious attempt in decades by the federal government to curb the broad use of antibiotics in farm animals. Pressure for action has mounted as the effectiveness of drugs important for human health has declined, and deaths from bugs resistant to antibiotics have soared. Food producers said they will abide by the rules, but some public-health advocates voiced concerns that loopholes could render the policy toothless.
“This is the first significant step in dealing with this important public-health concern in 20 years,” said David Kessler, a former FDA commissioner who has been critical of the agency’s track record on antibiotics. “No one should underestimate how big a lift this has been in changing widespread and long-entrenched industry practices.”
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Antibiotics, one of the wonder drugs of the 20th century, were initially used indiscriminately in people and animals, experts say. By the 1970s, public-health officials had become worried that overuse was leading to the development of infections resistant to treatment in humans. But for years, modest efforts by federal officials were thwarted by the powerful food industry and its lobbying power in Congress. The issue of antibiotic overuse in animals and drug resistance has since become one of the leading public-health concerns worldwide, with at least 2 million Americans falling sick every year and about 23,000 dying from antibiotic-resistant infections.
The agency has changed the rules so that food-animal producers would no longer be able to use antibiotics to make animals grow faster. It will accomplish that by asking manufacturers of the drugs to change the labels in a way that would make it illegal for farmers to use the medicines for growth promotion.
The changes, which were originally proposed in 2012, are voluntary for drug companies. But FDA officials said they believed the companies would comply, based on discussions during the public-comment period. The two drugmakers that represent a majority of such drug products have stated their intent to participate, FDA officials said Wednesday. Companies will have three months to tell the agency whether they will change the labels, and three years to carry out the new rules.
Additionally, the agency is requiring that licensed veterinarians supervise the use of antibiotics, effectively requiring farmers and ranchers to obtain prescriptions to be able to use the drugs for their animals. Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, said this was a substantial change from the way the industry has operated.
Consumer health advocates say it is an open question whether the rules will change how much antibiotics are consumed by animals. They say a loophole will allow animal producers to keep using the same low doses of antibiotics by arguing that they are needed to keep animals from getting sick, thereby avoiding the new ban on use for growth promotion.
“Even if all growth promotion approvals were withdrawn voluntarily, many antibiotics could still be used in similar ways,” said Keeve Nachman, a scientist at the Johns Hopkins Center for a Livable Future.
A more meaningful move, Nachman said, would be to ban the use of antibiotics for the prevention of disease. That would limit antibiotic uses to treatment of sickness that was diagnosed by a veterinarian, a much narrower category, he said.
One drug producer, Zoetis, said it approved of the changes.
“We believe that veterinarians should be involved in decisions regarding antibiotic use in food animals for the health of the animal and for the safety of the food supply,” the company said in a statement.
Dearth of detail
How broadly farmers use antibiotics to promote animal growth is unknown.
About 80 percent of antibiotics used on farms are given through feed, and an additional 17 percent are given in water. Just 3 percent are given by injection.
Public-health advocates applauded the FDA move.
“Restricting the use of antibiotics for growth promotion and increasing veterinary oversight is a promising start,” said Laura Rogers, director of the Pew Charitable Trusts’ human health and industrial farming campaign. “We’re particularly encouraged that major drugmakers are indicating they will comply and that the FDA acknowledges there is still more work to do.”
A spokeswoman for Zoetis, a major producer, said the change was not expected to have a big effect on company revenues because many of its drug products were also approved for therapeutic uses. Nachman said that was an indication that overall use might not decline under the new rules.
Rep. Louise Slaughter, D-N.Y., who has long championed tougher restrictions on antibiotic use, cited trends in Europe to argue that voluntary changes do not work.
The European Union urged agricultural companies to limit the use of antibiotics in food animals in 2006, but the total amounts used in animals stayed about the same, Slaughter said, because therapeutic use rose to compensate for the decline in growth-promotion use. She said that use declined only in countries, such as the Netherlands, that instituted limits and fines for noncompliance.
The Animal Health Institute, an association of animal-drug makers, said it supported the policy and “will continue to work with the FDA on its implementation.”
The National Pork Producers Council was less enthusiastic, saying simply that it expects “hog farmers, and the federally inspected feed mills they purchase feed from, will follow the law.”
It said it had always promoted cooperation between veterinarians and pork producers, but that now that relationship will be formalized.
“It is part of our ethical responsibility to utilize antibiotics responsibly and part of our commitment to public health and animal health,” the council said in a statement.