On January 6, 2012, the Food and Drug Administration published a Final Order (as a Final Rule) in the Federal Register prohibiting using the antibiotic cephalosporin for “disease prevention” in food-producing animals, particularly cattle, swine, chickens and turkeys. Cephalosporin helps prevent disease on ranches and farms where crowded animal conditions are prevalent. FDA’s Order is intended to prohibit the “prophylactic use” of cephalosporin in the major species of food-producing animals. While Cephalosporin will still be allowed to treat illness in animals (as this is not viewed as a prophylactic use), FDA’s order will have to a substantial impact on the agricultural community. Cephalosporin is commonly used in humans to treat pneumonia, skin/soft tissue infections, pelvic inflammatory disease, diabetic foot infections, and urinary tract infections. FDA believes that bacterial resistance to cephalosporin has the potential to impact public health as the antibiotic (e.g., Keflex and generic Cephalexin) is regularly used to treat pneumonia and salmonella infections. Testing conducted by the Centers for Disease Control in 2009 found roughly 3 percent of salmonella tested was cephalosporin-resistant. While many in industry have charged that FDA needs a stronger scientific basis in order to justify imposing use restrictions on ranchers and farmers, US Rep. Louise M. Slaughter, D-NY, (among others) believes FDA should broaden the Order.

We expect this issue to remain contentious for both government and the farm/agricultural industry for the foreseeable future. Significantly, FDA is accepting public comments on the Order through March 6, 2012. The new restrictions are set to become effective on April 5, 2012. Interested parties who may be adversely impacted by the Order may submit comments to FDA and provide recommendations to make the Order less onerous to the agriculture community.

To view the Final Order, please click here.