Re-evaluation of a microbiological acceptable daily intake for tylosin based on its impact on human intestinal microflora

Abstract As veterinary drugs available for fish is very restricted, there growing trials repurposing livestock as aquatic animal drugs. Tylosin one of the most effective antibiotics to treat bacterial infections approved livestock, and would be used in fish. Hence, we investigated toxicological microbiological aspects tylosin establish health-based guidance value (HBGV) maximum residue limit (MRL) fishes, reevaluated acceptable daily intake (mADI) based on updated relevant data international guildeline. Lastly, exposure assessment was performed confirm appropriateness MRL. By investigating microbiologcial studies tylosin, point departure determined 0.308 μg/mL, which mean 50% minimum inhibitory concentration (MIC 50 ), obtained from Food Safety Committee Japan (FSCJ) evaluation report. Furthermore, a factor derivation mADI, volume colon content recently changed 500 mL compliance with International Cooperation Harmonization Technical Requirements Registration Veterinary Medicinal Products (VICH) guidelines. This previously defined mass (220 g). We applied correction 0.224 MIC equation since drug transformed metabolites reduced activity prior entering bound fecal materials within human. The mADI evaluated 0.01 mg/kg bw/day. Finally, hazard index, calculated by dividing estimated chronic dietary did not exceed 100%, suggesting that residues use unlikely public health concern. Overall, this study contributes significantly updating HBGV application concept first time Korea revised risk guidelines providing scientific rationale management food.