FDA Drafts Guidance on Food Safety Risk Assessment for Antibiotics Used in Animals
The U.S. Food and Drug Administration has released a new Draft Guidance for Industry, titled, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern. The document outlines a risk assessment approach to evaluate the microbial food safety risk of antimicrobial resistance (AMR) posed by new antimicrobial animal drugs.
As part of its pre-approval safety evaluation process, FDA will consider the potential impact on human health of all uses and classes of new antimicrobial animal drugs intended for use in food-producing animals. The draft guidance outlines a risk assessment method that takes into account the effects of the transmission of antimicrobial-resistant foodborne bacteria of concern to human health through the consumption of animal-derived food products. Although FDA’s primary focus will be foodborne pathogens and their resistance determinants, other enteric bacteria may be considered.