Washington, DC — 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.
On 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.
Despite 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;
- Stricter 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 supplies.
“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.”
Back in 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.”