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
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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2003-D-0433.