FDA’s Center for Veterinary Medicine (CVM) this past summer released its draft guidance on “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.”

The week before the document was released, the Dutch Valley dairy operation in Clovis, NM came in for an inspection by FDA.  It would find Dutch Valley’s animal drug use was not very judicious.

Dutch Valley had sold animal for sale as food that upon being slaughtered was subjected to tissue sample testing by USDA’s Food Safety and Inspection Service.  Those tests came back positive for sulfadimethoxine in liver tissue.

The analysis showed 0.333 parts per million (PPM).  FDA’s established tolerance level for the antibiotic is 0.1 PPM in the edible tissue of cattle.

In a July 29 warning letter to the New Mexican dairy, which was released this week, FDA said the high level of the antibiotic drug in the edible tissues of the meat means it is adulterated.

“The presence of this drug in the edible tissues of this animal in this amount causes the food to be adulterated…” the warning letter said.

The FDA letter said the dairy had administered the sulfa drug to the cow without following the dose level on the approved labeling.  It was given about double the dose level, a change that is not allowed unless done under the supervision of a licensed veterinarian.  

Dutch Valley’s misuse of animal drugs is just one example of how antibiotics can enter the food supply at higher than allowed levels.  The fear is this adds to human resistance to some antibiotics.

“Many factors contribute to the spread of antimicrobial resistance.  In some cases, doctors prescribe antimicrobials too frequently or inappropriately.  Sometimes patients do not complete the prescribed course of an antimicrobial, making it more likely that surviving microbes will develop resistance,” Dr. Joshua M. Sharfstein, FDA’s deputy commissioner, told Congress in July.

“Antimicrobial use in animals contributes to the emergence of resistant microorganisms that can infect people,” he added.   “Through international trade and travel, resistant microbes can spread quickly worldwide.”

In testimony before the House Subcommittee on Health, Dr. Sharfstein said: “This draft guidance is intended to inform the public of FDA’s current thinking on the use of medically important antimicrobial drugs in food-producing animals. 

” It is intended to help minimize antimicrobial resistance by outlining several broad principles for ensuring that medically important antimicrobial drugs are used judiciously in animal agriculture.”