FDA Policy/General

Veterinary Drug Human Food Residue Guidance

FDA has issued a guidance, Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD), to address the nature and types of data that can be useful in determining a toxicological acute reference dose for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data. The document was developed by a VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products) working group for adoption by regulatory bodies in the U.S., Japan, and the European Union.

The ARfD approach has been developed, the guidance says, to provide a human health guidance value for pesticides and other chemicals, including veterinary drugs, when their use can result in residues high enough to cause adverse effects following acute or short-term exposures in people consuming large portions of food containing the residue. The document contrasts this approach with the acceptable daily intake that is established to address potential adverse effects following chronic or long-term exposure to residues in food.

The guidance says it can be used to address the nature and types of data that should be useful in determining an ARfD, the studies that may generate such data, and how the ARfD can be calculated based on these data. It is limited to the application of toxicological and pharmacological endpoints and offers special consideration for residues of veterinary drugs in contrast to the available guidances and guidances that address the derivation and use of the ARfD for human exposure to pesticides, contaminants, and chemicals other than veterinary drugs. It provides internationally harmonized technical recommendations for an ARfD used in support of veterinary product registration/approval.

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