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1;FDA/CVM;Any compound present in the edible tissues after treatment with the new animal drug.
Includes parent drug, metabolites, and any substance formed in or on food.
The definition is broad enough to include resistant bacteria.
;Human Food Safety Assessment;Assess the Microbial Food Safety of New Animal Drugs in the following categories:
Antimicrobial resistance development in drugs of human concern
Potential disruption and/or development of antimicrobial resistance in the human intestinal bacteria
; Risk = Hazard x Exposure;Using a Qualitative risk assessment approach
Assess antimicrobial drugs intended for food-producing animals regarding the development of antimicrobial resistance
Address human exposure to antimicrobial resistant microbes through ingestion of animal-derived food
;;The hazard has been defined as human illness
caused by an antimicrobial-resistant bacterium
attributable to an animal-derived food commodity
treated with a human antimicrobial drug of concern.
In some instances, a hazard characterization is sufficient for a particular antimicrobial drug;Describes factors related to an antimicrobial drug and its use in animals that contribute to the emergence of antimicrobial resistant bacteria or antimicrobial resistance determinants in the animal;Mechanism of Activity
Spectrum of Activity
Pharmacokinetics
Pharmacodynamics
Antimicrobial Resistance Mechanism
Antimicrobial Resistance Transfer
Selection Pressure
;Hazard: Emergence of Antimicrobial Resistance
Parameters:
Mechanism of Activity – Class of Drug, targeted action
Spectrum of Actvity – Gram +/- activity, susceptibility data
Antimicrobial Resistance mechanisms – Structural, efflux, gene
Antimicrobial Resistance Transfer – chromosomal, mobile element
Selection Pressure – co-selection
;Describes likelihood of human exposure to food-borne bacteria of human health concern through animal-derived food products
;Probability that humans consuming animal derived foods will be exposed to resistant
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