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JECFA Toolbox for Veterinary Drug Residues Risk Assessment

Section 6. Data requirements for a suitable veterinary drug residue risk assessment













FAO. 2024. JECFA Toolbox for Veterinary Drug Residues Risk Assessment – Section 6. Data requirements for a suitable veterinary drug residue risk assessment. Rome. 



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    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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    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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    JECFA Toolbox for Veterinary Drug Residues Risk Assessment
    Section 3.3. Marker residue depletion studies
    2024
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    A radiolabelled study may not represent the “real-world” use of the drug. Therefore, the ensuing total residue depletion data may not accurately predict real-world residue concentrations. To determine likely “real-world” drug residues, it is necessary to conduct a separate marker residue depletion study. Consult the guidance document on marker residue depletion studies to: • understand why a marker residue depletion study is required in addition to a total residue study;• learn about the characteristics of a well-performed marker residue depletion study; • find relevant guidance documents regarding marker residue depletion study design and analytical methodology; and• access a hypothetical data set to begin practicing drug residue depletion data analysis.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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    The Joint FAO/WHO Meeting on Pesticide Residues (JMPR) comprises the FAO Panel on Pesticide Residues and the WHO Core Assessment Group. The WHO Core Assessment Group is responsible for reviewing pesticide toxicological data and estimating acceptable daily intake (ADI) and acute reference doses (ARfDs) and characterizing other toxicological criteria. The FAO Panel on Pesticide Residues reviews the results of a range of studies including residue field trials and processing studies. These studies, called evaluations, are conducted for each individual pesticide and published in this report for the benefit of national governments who may use the information while undertaking national assessments.
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