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BookletTraining materialJECFA Toolbox for Veterinary Drug Residues Risk Assessment
Section 6. Data requirements for a suitable veterinary drug residue risk assessment
2024A broad array of data is necessary to successfully complete the risk assessment. But in the real world, data sets are only as robust as their weakest link. In this guidance document on data requirements, you will learn about: • the impact of data gaps, small sample sizes, excessive variance in results, and generally poor data quality on the subsequent risk assessment and MRL derivation;• the types of data that are critical for completing the hazard, residue and exposure portions of a veterinary drug residue risk assessment; and• the specific characteristics of a drug compound that make residue assessments simpler or more challenging. 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. -
BookletTraining materialJECFA 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
2024By 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. -
BookletTraining materialJECFA 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
2024Specific 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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BookletCorporate general interestFAOSTYLE: English 2024The objective of having a house style is to ensure clarity and consistency across all FAO publications. Now available in HTML, this updated edition of FAOSTYLE: English covers matters such as punctuation, units, spelling and references. All FAO staff, consultants and contractors involved in writing, reviewing, editing, translating or proofreading FAO texts and information products in English should use FAOSTYLE, together with the practical guidance on processes and layout questions provided in Publishing at FAO – strategy and guidance.
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