The rule would apply to major food-producing species, including cattle, swine, chickens and turkeys.

Currently, animal drug sponsors are not required to submit sales or distribution data by particular species, although they do provide annual summary reports.

The USDA say the additional data would improve understanding of how antimicrobials are sold or distributed for use in major food-producing animals, and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials.

“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,” said Michael R. Taylor, deputy commissioner for foods and veterinary medicine, at the FDA.

“We plan further actions to complete the task.”

Current regulatory authority limits the data collection that FDA can mandate to antimicrobial sales and distribution information.

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 FDA is actively engaged with the U.S. Department of Agriculture, Centers for Disease Control and Prevention, and a wide array of stakeholders to fill this need.

The FDA is accepting public comments on the proposed regulation for 90 days from the date of publication of the notice of availability in the Federal Register.

Further Reading

Electronic comments on the proposal can be submitted here.