In a 2-1 decision, the U.S. Second Circuit Court of Appeals in New York ruled Thursday that the U.S. Food and Drug Administration is not required to hold hearings concerning the safety of feeding antibiotics at subtherapeutic levels.
The ruling overturns two district court rulings from 2012 in a case initially filed in 2011 by the Natural Resources Defense Council (NRDC), the Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, and the Union of Concerned Scientists.
The groups argue that FDA is required by statute to hold hearings to determine whether to withdraw approval for the use of penicillin and tetracyclines in animal feed after the agency declared that the subtherapeutic use of the drugs in animal feed “ha[s] not been shown to be safe” in the late 1970s.
Such hearings would be a requirement for industry to prove that the use of these drugs as approved is safe.
“If they were not able to do that, then FDA would have to proceed with withdrawing the approvals for those drugs, which would effectively ban those drugs in animals for food production,” said Keeve Nachman, a scientist at the Johns Hopkins Center for a Livable Future.
NRDC says that not requiring hearings means FDA “does not have to consider banning” the practice of feeding antibiotics to healthy animals.
“The science was there in 1977 and 40 years later, it’s only gotten stronger that these low-dose, routine use of antibiotics on livestock is causing development of antibiotic-resistant bacteria and that bacteria is coming off the farm in many different ways and affecting humans,” said Mae Wu, an attorney with NRDC’s health program.
“Today’s decision allows the FDA to openly declare that a particular animal drug is unsafe, but then refuse to withdraw approval of that drug,” wrote Judge Robert Katzmann in his dissent. “It also gives the agency discretion to effectively ignore a public petition asking it to withdraw approval from an unsafe drug. I do not believe the statutory scheme can be read to permit those results.”
Part of FDA’s argument in the case has been Guidance #213, which will ban the use of antibiotics for growth promotion in food animals, as an alternative strategy for dealing with resistance. But NRDC and other groups have argued that it won’t be effective at curbing antibiotic use on farms because “disease prevention” labels could simply replace those for growth promotion.
The Centers for Disease Control and Prevention estimates that at least 23,000 people die each year from antibiotic-resistant infections.
“Because of the link between antibiotic use in food-producing animals and the occurrence of antibiotic-resistant infections in humans, antibiotics should be used in food-producing animals only under veterinary oversight and only to manage and treat infectious diseases, not to promote growth,” reads CDC’s report on antibiotic resistance threats, released last September.
Today’s decision was a “big blow to public health,” Nachman said. “It’s tough to know where it’s going to go from here. I would expect that NRDC would appeal this decision in some manner; I would hope they would.”
When asked if NRDC plans to appeal Thursday’s ruling, Wu told Food Safety News, “I can’t say today what we’re going to do because it takes a lot more discussion, but we’re not discounting any options at this point.”© Food Safety News