A federal judge has ordered the Food and Drug Administration to evaluate the safety risks to human health associated with the widespread use of antibiotics in food-producing animals, saying the agency has done "shockingly little" since proposing in the 1970s to order a substantial reduction in the use of antibiotics in animal feed.
U.S. Magistrate Judge Theodore Katz in Manhattan issued the order in a ruling filed on Monday. The decision largely agreed with the arguments of several health and consumer organizations that sued last year, saying the FDA violated federal law by failing to withdraw approval of using penicillin and tetracyclines in animal feed when animal health is not at stake.
Katz said the agency must evaluate the safety risks of the drugs and make a finding that they are unsafe _ or explain why it is refusing to do so.
He rejected the agency's argument that it had addressed the threat from antibiotics by initiating a voluntary program that encourages the industry to use the drugs "judiciously" because public hearings would consume extensive periods of time and agency resources.
"By refusing to make findings as to the drugs' safety _ or provide a statutorily based reason for refusing to make such findings _ the agency avoided the Congressionally mandated scheme for addressing drugs not shown to be safe," Katz wrote. "For over thirty years, the agency has been confronted with evidence of the human health risks associated with the widespread ... use of antibiotics in food-producing animals, and, despite a statutory mandate to ensure the safety of animal drugs, the agency has done shockingly little to address these risks."
The magistrate judge criticized the agency's complaint that the process mandated by Congress to address when a drug is found to be unsafe was not effective because it takes too long, saying it was it was ironic for the agency to make that complaint since hearings would have long been completed had they commenced in a timely fashion.
"One can only wonder what conceding the absence of an effective regulatory mechanism signals to the industry which the FDA is obligated to regulate," Katz said in a footnote.
Government lawyers already are appealing a March ruling by Katz in which he required the FDA to withdraw approval for uses of the antibiotics that the industry cannot prove are safe.
They have asked Katz and the 2nd U.S. Circuit Court of Appeals to suspend the effect of his rulings, saying "the unnecessary expenditure of public funds and resources is not in the public interest," especially since the agency is trying through its voluntary program to limit the use of 161 antibiotic drugs rather than the several at stake in the litigation. They added that staging hearings would force the FDA to divert resources from other agency programs that are important to its public health mission and could take years.
The FDA declined to comment, citing the ongoing litigation.
Last year's lawsuit noted that the FDA concluded in 1977 that feeding animals low doses of certain antibiotics could promote antibiotic-resistant bacteria that could infect people, but failed to act to curb their use. As a result, it said, about 80 percent of all antibiotics used in the United States are now used in livestock to promote faster animal growth on less feed, to treat sick animals and to prevent diseases that occur when animals are kept in cramped, unsanitary conditions.
The Natural Resources Defense Council Inc., an environmental and public health advocacy group that is one of the plaintiffs, has said the antibiotics are added to feed or water for pigs, cows, chickens and turkeys at levels too low to treat disease, enabling bacteria to survive in a form stronger and more resistant to medical treatment.
"The court's order pushes the agency one step closer to meaningful action to curb the dangerous overuse of antibiotics in animal feed," said Avinash Kar, one of the group's attorneys.
"This is a great victory for the public health," said Margaret Mellon, senior scientist of Union of Concerned Scientists, another plaintiff in the lawsuit. "The court has seen through the FDA's excuses and is ordering the agency to move expeditiously on critical issues that have dragged on for far too long."