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GUIDANCE DOCUMENT

CVM GFI #232 (VICH GL54) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD) August 2017

Final

CVM GFI #232 (VICH GL54) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)

Docket Number:
FDA-2015-D-1804
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The safety of residues of veterinary drugs in human food is most commonly addressed through the conduct of toxicology studies in test animal species that provide for the determination of a no-observed-adverse-effect level (NOAEL) and an acceptable daily intake (ADI) by application of appropriate safety/uncertainty factors (UF(s)). The ADI, generally expressed as microgram (μg) or milligram (mg)/kg body weight per day, is defined as the daily intake which, for up to an entire lifetime, appears to be without adverse effects or harm to the health of the consumer.

It has been recognized that there is the potential for some veterinary drug residues to cause adverse effects in the human consumer following a single meal. The ADI may not be the appropriate value in such cases for quantifying the level above which exposure after a single meal or over one day can produce acute adverse effects. Determining the ARfD is an appropriate approach to address this concern.

This guidance addresses the nature and types of data that can be useful in determining a toxicological acute reference dose (ARfD) for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data.


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-2015-D-1804.

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