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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 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 evaluati.
The monographs contained in this volume were prepared at the eighty-eighth meeting of the Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Veterinary drugs (JECFA), which met at WHO headquarters in Rome, Italy, 22–31 October 2019. These monographs summarize the data on selected veterinary drugs reviewed by the Committee.
This report represents the conclusions of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) convened to evaluate the safety of veterinary drug residues in food: clopidol, imidacloprid and fumagillin. Annexed to this report is a summary of the Committee’s recommendations on these drugs discussed at the ninety-eighth meeting, including acceptable daily intakes (ADIs), acute reference doses (ARfDs), estimated dietary exposure and proposed maximum residue limits (MRLs). Summaries are also provided for general considerations around the matters of interest arising from previous sessions of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF), update of Guidance for the Safety Evaluation of Residues of Veterinary Drugs with incomplete data packages, and release of JECFA Toolbox for Veterinary Drug Residues Risk Assessment. This volume and others in the WHO Technical Report Series contain infrmation that is useful to those who produce and use veterinary drugs, and those involved with controlling contaminants in food, government and food regulatory officers, industrial testing laboratories, toxicological laboratories and universities.
The report contains the monographs that were prepared at the eighty-eighth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which took place at the headquarters of the Food and Agriculture Organization of the United Nations (FAO) in Rome on 22–31 October 2019. [Author] These monographs summarize the data on the safety of residues in food of selected veterinary drugs reviewed by the JECFA. [Author]
The monographs in this volume summarize data on the veterinary drug residues that were evaluated toxicologically by the Committee, which included three antimicrobial agents (cefuroxime, flumequine and pirlimycin), two insecticides (cyhalothrin, and cypermethrin and alpha-cypermethrin) and one production aid (ractopamine). The Committee also evaluated the safety of low levels of the antimicrobial agent chloramphenicol in animal products. 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.