Companies are now required to provide estimates of sales broken down by major food-producing species (cattle, swine, chickens and turkeys) in addition to the overall estimates they already submit on the amount of antimicrobial drugs they sell or distribute for use in food-producing animals. As it is now interpreted, the rule does not split reporting requirements for beef and dairy cattle.
Previous regulations required annual reports on amounts of all antimicrobial drugs sold and distributed, by drug class. The FDA said the increased reporting will help further target efforts to ensure judicious use of medically important antimicrobials.
The rule is effective July 11 and requires enhanced reporting on all 2016 sales. The FDA will publish an annual summary of the data by Dec. 31 of the following year.
More reporting requirements may reach all the way to the farm. According to the rule posted on the Federal Register, the FDA is collaborating with the USDA and the Center for Disease Control (CDC) to develop a plan for collecting additional on-farm data on antimicrobial use and resistance.
Read the rule posted in the Federal Register.
Data from multiple sources are needed to provide a comprehensive and science-based picture of antimicrobial drug use and resistance in animal agriculture, and ensure the continued availability of safe and effective antimicrobials for use in treating animals and humans, the FDA wrote.
Slaughter wants on-farm surveillance
U.S. Rep. Louise Slaughter (D-N.Y.), a longtime proponent of restrictions on antimicrobial use in livestock, said the requirement is one step toward increased scrutiny.
“I will continue to push the FDA to quickly expand its efforts to on-farm surveillance so that new antibiotics remain effective and don’t go the way of current drugs,” she said.
Animal Health Institute disappointed
The Animal Health Institute (AHI), representing companies producing animal and livestock medicines, expressed disappointment in the final rule. It said a secure and confidential program like the USDA National Animal Health Monitoring System (NAHMS) is a more appropriate system for collecting this type of information.
“We believe this rule will result in an inaccurate representation of the data that will be misleading and not contribute to sound decision making,” the AHI statement said. “Asking drug sponsors to estimate sales data will lead to imprecise numbers that will be used as definitive measures of antibiotic use. Further, sales data does not correlate with antimicrobial resistance or public health.”
AHI said it voluntarily collected and published sales data before it was mandated by law and is working with agricultural, veterinary and public health groups in support of proposed USDA funding to appropriately collect information and research that will aid in better understanding of antibiotic use.
“We strongly encourage the FDA to reconsider this ruling and instead develop a comprehensive plan for antibiotic data collection that is clear in its goals and provides information that will aid all users in making decisions about the use of antibiotics,” AHI concluded. 
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