FDA Finalizes Guidance for Assessing Human Health Risks of Antimicrobial Use in Food-Producing Animals
The U.S. Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine has updated its framework for assessing antimicrobial resistance (AMR) risks of using antimicrobial drugs in food-producing animals with the release of a new final guidance.
AMR is recognized as a crucial threat to global public health, and antimicrobial use in animal agriculture can contribute to the emergence and spread of increasingly drug-resistant foodborne pathogens. Literature suggests that an estimated 4.95 million deaths worldwide were associated with bacterial AMR in 2019, including 1.27 million deaths directly attributable to AMR. Additionally, an estimated 70 percent of all antibiotics used in the U.S. in 2015 were consumed by animals. Drug-resistant Campylobacter and non-typhoidal Salmonella were estimated to cause 448,400 and 212,500 U.S. infections, respectively, in 2019.
Because some antimicrobial classes used in animals are also important to human medicine, FDA evaluates potential human health risks from AMR when reviewing new animal drug applications. The guidance—known as Guidance for Industry (GFI) #152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern—provides a qualitative risk assessment framework for determining whether, and to what degree, antimicrobial use in food-producing animals could pose a human health risk through the food supply.
GFI #152 also includes Appendix A, which ranks antimicrobial drugs by their relative importance to human medicine as critically important, highly important, or important. FDA clarified that these rankings inform its risk assessments but are not intended as a standalone risk management tool.
FDA first issued GFI #152 in 2003 and published draft revised guidance in 2022. The final version provides additional detail on hazard characterization, consolidates discussion of risk management, clarifies the intended use of Appendix A rankings, and explains why topical antimicrobials are excluded from rankings of medically important antimicrobial drugs.
The overall purpose of GFI #152 has remained unchanged; it serves as FDA’s primary framework for evaluating potential AMR risks to human health from antimicrobial drug use in food-producing animals.
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