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JECFA Toolbox for Veterinary Drug Residues Risk Assessment

Section 3.1. Total residues: How to characterize components of a veterinary drug residue










FAO. 2024. JECFA Toolbox for Veterinary Drug Residues Risk Assessment  Section 3.1. Total residues: How to characterize components of a veterinary drug residue. Rome.



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    Booklet
    JECFA Toolbox for Veterinary Drug Residues Risk Assessment
    Section 4.1. JECFA’s approach for assessing dietary exposure to veterinary drug residues: Estimating total residues for use in dietary exposure assessment
    2024
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    By this point, you will understand the roles of both the total residue and marker residue depletion studies. Consult the guidance document to: • review how the M:T ratios are calculated in edible tissues at any time point after drug administration; and• see how total residue estimates are calculated based on the marker residue depletion and M:T data. This publication is part of the FAO JECFA Toolbox for Veterinary Drug Residue Risk Assessment. The toolbox provides practical guidance on the principles, modalities and technical requirements of JECFA in assessing the risks of veterinary drug residues in food and in recommending MRLs.
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    Booklet
    JECFA Toolbox for Veterinary Drug Residues Risk Assessment
    Section 2. Hazard assessment: How health-based guidance values are derived and used in the JECFA drug residue risk assessment
    2024
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    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.This publication is part of the FAO JECFA Toolbox for Veterinary Drug Residue Risk Assessment. The toolbox provides practical guidance on the principles, modalities and technical requirements of JECFA in assessing the risks of veterinary drug residues in food and in recommending MRLs.
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    Booklet
    JECFA Toolbox for Veterinary Drug Residues Risk Assessment
    Section 3.2. Marker residues and the marker to total residue ratio
    2024
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    Regulatory authorities need to monitor for residues of veterinary drugs in food. Monitoring laboratories cannot easily quantify “total” drug residues. To detect total residues, the monitoring laboratory would need assays that detect and quantify all residue components (i.e. every metabolite). Rather than attempting to monitor total residues in food, the regulatory agencies instead monitor for a marker residue (MR). Consult the guidance document to learn about:• the characteristics of a suitable MR with examples for different types of MRs; • the relationship between marker residues and total residues, particularly how the ratio of marker to total (M:T) residues varies between edible tissues and over time; and• alternative approaches to total residue assessment, such as the residue of concern (RoC) and related concepts like bioavailability and bioaccessibility.This publication is part of the FAO JECFA Toolbox for Veterinary Drug Residue Risk Assessment. The toolbox provides practical guidance on the principles, modalities and technical requirements of JECFA in assessing the risks of veterinary drug residues in food and in recommending MRLs.

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