CVM GFI #159 (VICH GL36) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI January 2022

GUIDANCE DOCUMENT

• Docket Number: FDA-2003-D-0433
• Issued by: Center for Veterinary Medicine

A variety of toxicological evaluations can be performed to establish the safety of veterinary drug residues in human food. An issue that needs to be addressed for veterinary antimicrobial drugs is the safety of their residues on the human intestinal flora. The objectives of this guidance are (1) to outline the recommended steps in determining the need for establishing a microbiological acceptable daily intake (ADI); (2) to recommend test systems and methods for determining no-observable adverse effect concentrations (NOAECs) and no-observable adverse effect levels (NOAELs) for the endpoints of health concern; and (3) to recommend a procedure to derive a microbiological ADI.

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