Specific types of toxicological and microbiological data are essential for performing a robust hazard assessment of veterinary drug residues. The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and other agencies provide guidance on the design and analysis of such studies.

Consult the guidance document on hazard assessment to learn how JECFA identifies key study outcomes and subsequently derives relevant HBGVs, including the following processes:

• Toxicological studies: Determining the no observable adverse effect level (NOAEL) from toxicological studies and selecting an appropriate uncertainty (safety) factor (UF);
• Microbiological studies: How minimum inhibitory concentration (MIC) data can be used to assess relevant microbiological endpoints, such as disruption of the colonization barrier in the human colon and emergence of antimicrobial resistance;
• Derivation of both chronic (acceptable daily intake) and acute (acute reference dose) health-based guidance values, and the difference between these HBGVs.