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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. -
BookletTraining materialJECFA Toolbox for Veterinary Drug Residues Risk Assessment
Section 3.2. Marker residues and the marker to total residue ratio
2024Regulatory 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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BookletTraining materialJECFA Toolbox for Veterinary Drug Residues Risk Assessment
Section 5. Deriving maximum residue limits (MRLs)
2024In this guidance document on MRLs you will: • compare the drug residue exposure estimates (calculated in Section 4.2) with the relevant health-based guidance values (ADI/ARfD, Section 2) to assess the risk of residues at various times after drug administration;• see how potential MRL values are derived based on 95/95 UTL marker residues, once exposure estimates are deemed sufficiently protective of human health; and• learn about the factors influencing the selection of suitable MRLs, such as withdrawal periods of approved drug products. 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 1. The JECFA risk assessment process
2024Veterinary drug residues from animal-derived food products may pose risks to human health. To perform a drug residue risk assessment, we must first characterize the risk by evaluating the hazard and assessing exposure. Consult the guidance document for a brief description of the relevant data necessary for the evaluation process, followed by the key outcomes and relevant JECFA experts responsible along each step of the JECFA risk assessment process:• Hazard assessment: Derivation of health-based guidance values (HBGVs) such as acceptable daily intake (ADI) and acute reference dose (ARfD);• Residue assessment: Total residue (TR) and marker residue (MR) depletion in edible tissues;• Exposure assessment: Use of the global estimated chronic or acute dietary intake; and • How maximum residue limits (MRLs) are derived as the final step of the JECFA risk assessment process. 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. -
Book (series)FlagshipThe State of Food Security and Nutrition in the World 2023
Urbanization, agrifood systems transformation and healthy diets across the rural–urban continuum
2023This report provides an update on global progress towards the targets of ending hunger (SDG Target 2.1) and all forms of malnutrition (SDG Target 2.2) and estimates on the number of people who are unable to afford a healthy diet. Since its 2017 edition, this report has repeatedly highlighted that the intensification and interaction of conflict, climate extremes and economic slowdowns and downturns, combined with highly unaffordable nutritious foods and growing inequality, are pushing us off track to meet the SDG 2 targets. However, other important megatrends must also be factored into the analysis to fully understand the challenges and opportunities for meeting the SDG 2 targets. One such megatrend, and the focus of this year’s report, is urbanization. New evidence shows that food purchases in some countries are no longer high only among urban households but also among rural households. Consumption of highly processed foods is also increasing in peri-urban and rural areas of some countries. These changes are affecting people’s food security and nutrition in ways that differ depending on where they live across the rural–urban continuum. This timely and relevant theme is aligned with the United Nations General Assembly-endorsed New Urban Agenda, and the report provides recommendations on the policies, investments and actions needed to address the challenges of agrifood systems transformation under urbanization and to enable opportunities for ensuring access to affordable healthy diets for everyone.