May 19, 2015
by Erica Shaffer
WASHINGTON – The Food and Drug Administration is proposing a rule that would include species-specific information as part of the agency's reporting requirements for drug sponsors of antimicrobials sold for use in food-producing animals.
“Consistent with data collection objectives outlined in the Administration’s National Strategy for Combating Antibiotic-Resistant Bacteria, this proposed rule is a step toward providing more detailed information to the FDA and the public on changes in antimicrobial sales and distribution over time,” Michael R. Taylor, deputy commissioner for foods and veterinary medicine, FDA, said in a statement. “We plan further actions to complete the task.”
Currently, FDA can mandate reporting of antimicrobial sales and distribution information. The proposed revision would enable the agency to develop estimates of sales by major food-producing species — cattle, swine, chickens and turkeys.
In 2014, lawmakers urged FDA to increase data collection on the use of antibiotics in agriculture. In a letter to the agency four US Senators said improving the stewardship of how antibiotics are used and surveillance of antibiotic resistance must be national priorities.
“While adding species-specific information will help provide a fuller picture, more detailed information is needed about on-farm use practices to adequately understand links between usage patterns and trends in resistance,” the agency said. “FDA is actively engaged with the US Department of Agriculture, Centers for Disease Control and Prevention, and a wide array of stakeholders to fill this need.”
FDA also is required to publish an annual summary report of antimicrobial sales and distribution. The proposed rule includes a provision that would require FDA to publish its annual summary report by Dec. 31 of the following year.
The FDA is accepting public comments on the proposed rule beginning on May 20. The comment period will close 90 days after publication in the Federal Register
. Electronic comments should be submitted to www.regulations.gov