NCTR Research Highlights

Current Highlight from October 7, 2016

Safety Evaluation of Veterinary Antimicrobial Drug Residues in Food

Scientists from NCTR, FDA's Center For Veterinary Medicine, and industry (Zoetis) have published a review on the safety evaluation of veterinary antimicrobial drug residues in food with regard to the human intestinal microbiome. The article describes the globally harmonized guideline, VICH GL36(R), which was issued by the International Cooperation on Harmonization of Technical Requirements for Veterinary Medicinal Products (VICH). The guideline is used by national and international regulatory agencies to assess the effects of animal drug residues in animal-derived food on human intestinal bacteria. The review:

describes the steps in the VICH GL36(R) guideline to derive a microbiological acceptable daily intake (mADI)
provides insights on the microbiological endpoints of human health concern used to determine the mADI
describes research issues related to the potential development of antimicrobial resistance due to exposure to residual levels of antimicrobial drugs in food
identifies current research gaps in the relationship between animal-drug residue levels, the human intestinal microbiome, and human health.

This publication is now available online at Drug Testing and Analysis.

For more information, please contact Carl Cerniglia, Director, Division of Microbiology, FDA/NCTR.