The Food and
Drug Administration on Wednesday put in place a major new policy to
phase out the indiscriminate use of antibiotics in cows, pigs and
chickens raised for meat, a practice that experts say has
endangered human health by fueling the growing epidemic of
antibiotic resistance.
This is the
agency’s first serious attempt in decades to curb what experts have
long regarded as the systematic overuse of antibiotics in healthy
farm animals, with the drugs typically added directly into their
feed and water. The waning effectiveness of antibiotics — wonder
drugs of the 20th century — has become a looming threat to public
health. At least two million Americans fall sick every year and
about 23,000 die from antibiotic-resistant
infections.
“This is the first significant step in
dealing with this important public health concern in 20 years,”
said David Kessler, a former F.D.A. 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.”
The change, which is to take effect
over the next three years, will effectively make it illegal for
farmers and ranchers to use antibiotics to make animals grow
bigger. The producers had found that feeding low doses of
antibiotics to animals throughout their lives led them to grow
plumper and larger. Scientists still debate why. Food producers
will also have to get a prescription from a veterinarian to use the
drugs to prevent disease in their
animals.
Federal officials said the new policy
would improve health in the United States by tightening the use of
classes of antibiotics that save human lives, including penicillin,
azithromycin and tetracycline. Food producers said they would abide
by the new rules, but some public health advocates voiced concerns
that loopholes could render the new policy
toothless.
Health officials have warned since the
1970s that overuse of antibiotics in animals was leading to the
development of infections resistant to treatment in humans. For
years, modest efforts by federal officials to reduce the use of
antibiotics in animals were thwarted by the powerful food industry
and its substantial lobbying power in Congress. Pressure for
federal action has mounted as the effectiveness of drugs important
for human health has declined, and deaths from bugs resistant to
antibiotics have soared.
Under the new
policy, the agency is asking drug makers to change the labels that
detail how a drug can be used so they would bar farmers from using
the medicines to promote growth.
The changes,
originally proposed in 2012, are voluntary for drug companies. But
F.D.A. officials said they believed that the companies would
comply, based on discussions during the public comment period. The
two drug makers that represent a majority of such antibiotic
products — Zoetis and Elanco — have already stated their intent to
participate, F.D.A. officials said. 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 use the drugs for their
animals.
“It’s a big shift from the current
situation, in which animal producers can go to a local feed store
and buy these medicines over the counter and there is no oversight
at all,” said Michael Taylor, the F.D.A.’s deputy commissioner for
foods and veterinary medicine.
Some consumer
health advocates were skeptical that the new rules would reduce the
amount of antibiotics consumed by animals. They say that a loophole
will allow animal producers to keep using the same low doses of
antibiotics by contending they are needed to keep animals from
getting sick, and evading the new ban on use for growth
promotion.
More meaningful, said Dr. Keeve
Nachman, a scientist at the Johns Hopkins Center for a Livable
Future, would be to ban the use of antibiotics for the prevention
of disease, a step the F.D.A. so far has not taken. That would
limit antibiotic uses to treatment of a specific sickness diagnosed
by a veterinarian, a much narrower category, he
said.
Another skeptic, Representative Louise
M. Slaughter, a Democrat from New York, said that when the European
Union tried to stop companies from using antibiotics to make farm
animals bigger, companies continued to use antibiotics for disease
prevention. She said antibiotic use only declined in countries like
the Netherlands that instituted limits on total use and fines for
noncompliance.
But another
longtime critic of the F.D.A. on antibiotics, Dr. Stuart B. Levy, a
professor of microbiology at Tufts University and the president of
the Alliance for the Prudent Use of Antibiotics, praised the new
rules. He was among the first to identify the problem in the 1970s.
“I’m kind of happy,” he said. “For all of us who’ve been struggling
with this issue, this is the biggest step that’s been taken in the
last 30 years.”
Mr. Taylor, the
agency official, said the F.D.A. had detailed what veterinarians
needed to consider when they prescribed such drugs. For example,
use has to be for animals at risk for developing a specific
disease, with no reasonable alternatives to prevent
it.
“It’s far from being a just-trust-them
system,” he said. “Given the history of the issue, it’s not
surprising that there are people who are
skeptical.”
He added that some food producers had
already curbed antibiotic use.
A spokeswoman
for Zoetis, a major drug producer that said it would abide by the
new rules, said the new policy was not expected to have a big
effect on the revenues of the company because many of its drug
products were also approved for therapeutic uses. (Dr. Nachman said
that was an indication that overall use might not decline under the
new rules.)
The Animal Health Institute, an
association of pharmaceutical companies that make drugs for
animals, said that it supported the policy and “will continue to
work with the F.D.A. on its
implementation.”
The National
Pork Producers Council was less enthusiastic, saying, “We expect
that hog farmers, and the federally inspected feed mills they
purchase feed from, will follow the
law.”
“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.
The National Chicken Council said in a
statement that its producers already worked closely with
veterinarians, and that much of the antibiotics used in raising
chickens were not used in human
medicine.