A federal judge said the Food and Drug Administration (FDA) had done "shockingly little" to address the human health risks of antibiotic use in animal feed and ordered the agency to reconsider two petitions seeking restrictions on the practice.
The ruling, filed last week in a lawsuit brought by environmental and public-health groups, is the second recent setback for the FDA amid long-standing concern that overuse of antibiotics in animal feed is endangering human health by creating antibiotic-resistant bacteria.
U.S. Magistrate Judge Theodore Katz in New York questioned the federal agency's arguments that it would be less costly and more efficient to ask the industry to voluntarily cut back on the use of such antibiotics, rather than go through the regulatory process of revoking the approval of such drug use on farms and at feed lots.
"For over thirty years, the Agency has been confronted with evidence of the human health risks associated with the widespread subtherapeutic 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," Katz wrote.
In March, Katz ordered the FDA to complete proceedings to withdraw approval for the non therapeutic use of penicillin and tetracycline in livestock production unless makers of the drugs can produce evidence that their use is safe. The agency started the process in 1977, but never completed it.
The FDA declined on Tuesday to comment on the latest ruling. It filed a notice of appeal last month of the March order.
In his latest ruling, Katz found that the FDA behaved in an "arbitrary and capricious" manner when it dismissed two citizens' petitions that asked the agency to consider banning farmers from using antibiotics on livestock for non-therapeutic uses.
The FDA had rejected the two petitions - filed in 1999 and in 2005 - because of the time and expense to hold formal withdrawal proceedings.
YEARS OF CONCERN
As far back as 1972, a federal scientific task force found that the use of low-level doses of antibiotics in animal feed favored the development of antibiotic-resistant bacteria; that such bacteria had been found on meat sold to the public; and that the prevalence of such bacteria in humans had increased.
Katz's latest ruling adds fuel an intensifying legal war over the future use of antibiotics to promote animal growth, increase feed efficiency and disease prevention on food-producing livestock.