Residue Evaluation Of Certain Veterinary Drugs

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of residues of certain veterinary drugs in food and to recommend maximum levels for such residues in food. The first part of the report considers general principles regarding the evaluation of veterinary drugs within the terms of reference of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), including a hypothesis-driven decision tree approach for the safety evaluation of residues of veterinary drugs; comments on the Committee for Veterinary Products for Medicinal Use reflection paper on the new approach developed by JECFA for exposure and maximum residue limit (MRL) assessment of residues; residues of veterinary drugs in honey and possible approaches to derive MRLs for this commodity; comments on a paper entitled "Risk-assessment policies: Differences among jurisdictions"; and the use of no-observed-effect level (NOEL) and no-observed-adverse-effect level (NOAEL) in JECFA assessments. Summaries follow of the Committee's evaluations of toxicological and residue data on a variety of veterinary drugs: three antimicrobial agents (avilamycin, tilmicosin, tylosin), one authentic (triclabendazole), one production aid (melengestrol acetate), two antimicrobial agents and production aids (monesin and narasin), a glucocorticosteroid (dexamethasone) and an antimicrobial agent ands contaminant (malachite green). Annexed to the report is a summary of the Committee's recommendations on these drugs, including acceptable daily intakes (ADI's) and proposed MRL's.

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of residues of certain veterinary drugs in food and to recommend maximum levels for such residues in food. The first part of the report considers general principles regarding the evaluation of veterinary drugs within the terms of reference of JECFA, including compounds without an ADI or MRL; recommendations on principles and methods in derivation of MRLs, including a new procedure for estimating chronic dietary intakes; the use of a spreadsheet-based procedure for the statistical evaluation of residue depletion data; a revised approach for the derivation of microbiological ADIs; and the Committee's review of and comments on documents provided by the Codex Committee on Residues of Veterinary Drugs. Summaries follow of the Committee's evaluations of toxicological and residue data on a variety of veterinary drugs: three antimicrobial agents (colistin, erythromycin, flumequine), two production aids (melengestrol acetate, ractopamine hydrochloride, an insecticide (trichlorfon (metrifonate)), and an anthelminthic (triclabendazole). In addition, the attempt by the Committee to use tylosin as an example to investigate if evaluations are possible based on published data in the absence of data submissions from sponsors is described. Annexed to the report is a summary of the Committee's recommendations on these drugs, including acceptable daily intakes and proposed maximum residue limits.

This document contains monographs on residue evaluations of certain veterinary drugs, prepared at the seventy-eight meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which was held in Geneva, Switzerland, from 5 to 14 November 2013. Four substances were evaluated for the first time--emamectin benzoate, gentian violet, lasalocid sodium and zilpaterol hydrochloride. Four additional substances were re-evaluated--derquantel, ivermectin, monepantel and recombinant bovine somatotrophins. The monographs provide information on chemical identity and properties of the compounds, pharmacokinetics and metabolism, residue depletion studies and analytical methods validated and used for the detection and quantification of the compounds. In addition, this document provides an overview of the pilot project to evaluate alternative approaches to estimate daily intakes of residues of veterinary drugs in foods and provides guidance on the extrapolation of MRLs to minor species and for the establishment of MRLs in honey. This publication and other documents produced by JECFA contain information that is useful to all those who work with or are involved with recommending or controlling maximum residue limits for veterinary drugs in foods of animal origin.

Joint FAO/WHO Expert Committee on Food Additives, 66th meeting, Rome, 22-28 February 2006

In light of growing use of veterinary drugs in animal production systems, this report provides evaluations of eight veterinary drugs found in food, including amoxicillin, ampicillin and ethion. It covers identity of substance, residues in food and metabolism studies.

This volume contains monographs prepared at the eighty-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which met in Geneva, Switzerland, from 17 to 26 October 2017. [Author] The toxicological monographs in this volume summarize data on the veterinary drug residues that were evaluated toxicologically by the Committee: amoxicillin, ampicillin, ethion, flumethrin, halquinol and lufenuron. [Author] Annexed to the report is a summary of the Committee’s recommendations on these and other drugs discussed at the eighty-fifth meeting, including acceptable daily intakes (ADIs), acute reference doses (ARfDs) and proposed maximum residue limits (MRLs). [Author] This volume and others in the WHO Food Additives Series contain information that is useful to those who produce and use food additives and veterinary drugs and those involved with controlling contaminants in food, government and food regulatory officers, industrial testing laboratories, toxicological laboratories and universities. [Author]