For Immediate Release
Kyla Bennett (508) 230-9933; Kirsten Stade (202) 265-7337
Antimicrobial Drugs in Livestock Threaten Human Health
FDA Voluntary "Judicious Use" Plan Too Weak and Narrow to Abate Risks
WASHINGTON - Routine massive use of antimicrobial drugs on livestock poses direct
dangers to human health and the environment, according to regulatory
comments filed today by Public Employees for Environmental
Responsibility (PEER). Yet, the latest U.S. Food and Drug
Administration plan is a limited voluntary approach that will not stem
growing antibacterial resistance (in the form of so-called drug
resistant "super bugs") created by overuse of the drugs.
June 28, 2010, FDA published a guidance document entitled "Judicious Use
of Medically Important Antimicrobial Drugs in Food-Producing Animals"
for a public comment period ending on August 30th. In the document, FDA
admits that antimicrobial misuse and overuse pose a "serious public
health threat" that is of "global significance." The agency further
notes that "the scientific community generally agrees that antimicrobial
drug use is a key driver for the emergence of antimicrobial-resistant
bacteria," which are no longer treatable by conventional drugs. Perhaps
most disturbing is the transmission of this resistance from animals to
humans through direct consumption as well as other pathways.
the alarming findings, the FDA prescription is a remarkably timid
non-enforceable guidance which is riddled with loopholes and overlooks
important considerations. PEER advocates stronger steps, including
mandatory rules and-
- A broader ban on antimicrobials for "routine disease prevention," a use that FDA would allow;
limits on what veterinarians can approve. By contrast, the FDA
guidance relies on veterinarian approval, even though many vets work for
the food producers; and
- Taking ecological impacts into
account in drug approvals. Antimicrobials from the animals are
contaminating rivers and ground water, including drinking water
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"Unless we have enforceable rules, the narrow
self-interest of livestock producers will trump public health concerns
just as they have done for decades," stated New England PEER Director
Kyla Bennett, an attorney and scientist formerly with the U.S.
Environmental Protection Agency. "It is time that we officially
recognize that antimicrobials given to animals end up in the environment
in ways that affect both humans and the environment."
1977, FDA proposed to withdraw new drug approvals for non-therapeutic
use of some anti-bacterial drugs in animal feed but Congress intervened
to nix that move. The agency appears to have been gun-shy on the issue
ever since, as indicated by, among other things, its reliance on a legal
device called a "categorical exclusion" to avoid doing full
environmental reviews before approving these animal drugs. A
categorical exclusion was the same tactic used to avoid environmental
reviews on the permit for the ill-fated BP Deepwater Horizon oil rig in
the Gulf of Mexico.
"FDA does not have a consistent position
with respect to animal antimicrobials. On one hand, the agency
acknowledges that there are risks of global significance, but on the
other hand says that there is no significant environmental issue which
merits review," said PEER Staff Counsel Christine Erickson. "We urge
FDA to start conducting full environmental reviews before approving
these products for the market."
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