Guidance document for the establishment of Acute Reference Dose (ARfD) for veterinary drug residues in food

Overview

This document provides guidance on when it is necessary and how to establish an oral acute reference dose (ARfD) for residues of veterinary drugs.

The safety of veterinary drug residues in human food is typically assessed based on results from studies in laboratory animals. Human data, when available, and results from in vitro and in-silico studies are also considered in this safety assessment. Because humans can be exposed chronically to veterinary drug residues through consumption of food, and because chronic exposures often have a lower threshold for toxic response than infrequent or acute exposures, residues of veterinary drugs in food are routinely evaluated for effects following chronic exposures, and a corresponding acceptable daily intake (ADI) is established. The ADI provides a human health-based guidance value (HBGV) for chronic or long-term exposures to residues in food, and is most often established from a point of departure (POD, e.g., no-observed-adverse-effect level (NOAEL)) identified from repeated dose exposure study(ies) in experimental animals.