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GUIDANCE DOCUMENT

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 March 2013

Final

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

Docket Number:
FDA-2003-D-0433
Issued by:
Guidance Issuing Office
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.


Submit Comments

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
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2003-D-0433.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002