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FAO Manual on the Submission and Evaluation of Pesticide Residues Data

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FAO Manual on the Submission and Evaluation of Pesticide Residues Data ISSNISSN 0259-2517 1020-055X 225 ESTUDIO FAOFAO Biotecnología agrícola INVESTIGACIÓNPLANT YPRODUCTION TECNOLOGIA Submission and evaluation of pesticide residues data for estima para países en desarrollo AND PROTECTION PAPER8 Resultados de un foro electrónico 225 Submission and evaluation En esta publicación se presenta un informe sobre las primeras seis conferencias mediante correo electrónico The firstorganizadas version of por this el manualForo electrónico on the submissionde la FAO sobre and la evaluation biotecnología of pesticideen la alimentación residues y datala agricultura, for of pesticide residues data estimationcelebradas of maximum entre marzo residue de 2000 levels y mayo in de food 2001. and Todas feed las was conferencias printed by contaron FAO in con1997 un as moderador, a working duraron documentaproximadamente with the dos aim meses of consolidating y se centraron the en proceduresla biotecnología used agrícola by the en FAO los Panelpaíses ofen experts desarrollo. on Las cuatro pesticideprimeras residues. conferencias The trataron FAO Manual de la idoneidad was revised para in los 2002 países and en indesarrollo 2009 incorporated de las biotecnologías additional actualmente for the estimation of informationdisponibles from enthe los JMPR sectores Report agrícola, of 1997-2009. pesquero, forestalSince then y ganadero. there have Las otras been dos many conferencias developments trataron in de las the scientificrepercusiones evaluation de process la biotecnología of the Joint agrícola Meeting sobre onel hambre Pesticide y la Residues seguridad (JMPR), alimentaria administered en los países by en FAO anddesarrollo the Wor y lasld Healthconsecuencias Organization. de los derechos The present de propiedad manual intelectual incorporates en la all alimentación relevant information y la agricultura en maximum residue levels and principles that are currently used by the JMPResos to países. estimate maximum residue levels (MRLs), supervised trials median residue (STMR) values and dietary risk from pesticide residues. The manual will constantly be revised and updated in the light of experience gained and developments in in food and feed residue data evaluation. Its aim is also to improve communication between the Codex Committee on Pesticide Residues (CCPR) and its member countries and other participants in the CCPR and to explain the procedures being adopted by the FAO Panel of the JMPR. Third edition tion of maximum residue levels in food and feed PESTICIDE RESIDUES ISBN 978-92-5-10913-3 ISSN 0259-2517 FAO 978 9251 091333 I5452E/1/03.16 Front Grey Page__Manual 2015 copy.pdf 1 22/01/2016 12:12:53 Submission and evaluation FAO PLANT of pesticide residues data PRODUCTION AND PROTECTION for the estimation of PAPER maximum residue levels 225 in food and feed Third edition C M Y CM MY CY CMY K FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS Rome, 2016 The designations employed and the presentation of material in this information product do not imply the expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United Nations (FAO) concerning the legal or development status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or products of manufacturers, whether or not these have been patented, does not imply that these have been endorsed or recommended by FAO in preference to others of a similar nature that are not mentioned. The views expressed in this information product are those of the author(s) and do not necessarily reflect the views or policies of FAO. ISBN 978-92-5-109133-3 © FAO, 2016 FAO encourages the use, reproduction and dissemination of material in this information product. Except where otherwise indicated, material may be copied, downloaded and printed for private study, research and teaching purposes, or for use in non-commercial products or services, provided that appropriate acknowledgement of FAO as the source and copyright holder is given and that FAO’s endorsement of users’ views, products or services is not implied in any way. All requests for translation and adaptation rights, and for resale and other commercial use rights should be made via www.fao.org/contact-us/licence-request or addressed to [email protected]. FAO information products are available on the FAO website (www.fao.org/publications) and can be purchased through [email protected]. FAO Manual on the Submission and Evaluation of Pesticide Residues Data PREFACE The basic principle of the work undertaken by members of the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), is the continuous evaluation of new scientific developments and guidance documents. In considering such initiatives, the members draw on their own experience to elaborate and apply new principles and approaches in the assessment of data. The aim being to make best use of all available information when making recommendations to the Codex Committee on Pesticide Residues (CCPR) and Codex Members in order to ensure consumer safety and facilitate international trade. The 3rd edition of the FAO Manual incorporates the current working principles applied by the FAO Panel for evaluation of pesticide residues to recommend maximum residue levels, STMR and HR values and to assess the dietary exposure of consumers. In addition to the general updating of the text, the third edition contains new information on the: x incorporation of the ‘Risk analysis principles applied by the CCPR’ in the working procedures of the JMPR; x method validation and performance criteria of analytical methods applied in supervised trials, including sample preparation and processing, and considering residues below LOQ; x risk assessment of metabolites and degradates of pesticides by applying the threshold toxicological concern, TTC, approach; x principles of grouping crops for recommending residue levels for commodity groups; x use of proportionality of residues for adjusting residue values to match cGAP; x application of the concept of ‘Global GAP’; x estimation of maximum residue levels based on the results obtained with the OECD MRL calculator; x refined procedures for estimation EMRL and residue levels for spices; x application of the GEMS/Food 17 cluster diet for estimation of long-term dietary intake of pesticide residues; The reporting of supervised trials are assisted with the attached electronic versions of the Excel templates and spreadsheets to the Manual that can be downloaded from the FAO Homepage http://www.fao.org/agriculture/crops/thematic-sitemap/theme/pests/jmpr/jmpr-docs/en/ The JMPR will continue its activities with respect to considering and refining assessment methodologies to ensure the best use is made of all available information. Where modifications to current practices are deemed warranted, the basis for such changes will be elaborated in the annual JMPR Reports. The reader is advised to consult the Reports for information on any such new developments. (http://www.fao.org/agriculture/crops/core- themes/theme/pests/jmpr/jmpr-rep/en/). iii FAO Manual on the Submission and Evaluation of Pesticide Residues Data ACKNOWLEDGEMENT Professor Árpád Ambrus, a FAO temporary advisor, prepared the manuscript for the third edition. During past years the Members of the FAO Panels took active part in the elaboration of the working principles, which are included in this and the previous editions. Mrs. Trijntje van der Velde-Koerts proposed substantial structural changes of the 3rd edition of the Manual to improve usability and facilitate the finding of relevant information. Professor Eloisa Dutra Caldas, Mr. Makato Irie, Dr. Dugald MacLachlan, Dr. Mi-Gyung Lee, Mr. David Lunn, Dr Samuel Margerison, Mr. Christian Sieke, Dr Anita Strömberg, Dr.Yukiko Yamada, and Dr Guibiao Ye provided additional suggestions for improving the clarity and relevance of the text. Dr Mi-Gyung Lee prepared Annex 2 of Appendix X. Mr. Christian Sieke provided the Excel template for calculation of animal burden Dr Yong Zhen Yang, FAO Joint Secretary, contributed with useful comments and suggestions to the preparation of the manuscript. All contribution and assistance are sincerely appreciated. Mr. Kevin Bodnaruk, FAO Editor, assisted with the editing of the text and with the style of the Manual layout. iv FAO Manual on the Submission and Evaluation of Pesticide Residues Data CONTENTS PREFACE iii ACKNOWLEDGEMENT iv CONTENTS v CHAPTER 1 1 INTRODUCTION 1 1.1 Scope of this manual 1 1.2 Historical background 1 1.3 The object of the work of JMPR 3 1.4 The JMPR assessment process 4 1.5 Data and information required for JMPR evaluations 6 1.5.1 New and periodic reviews 6 1.5.1.1 New and existing MRLs 8 1.5.1.2 GAP information. 9 1.5.1.3 Supporting studies. 9 1.5.2 Re-evaluations 9 CHAPTER 2 11 PREPARATION OF DATA DOSSIERS FOR THE CONSIDERATION OF THE FAO PANEL OF JMPR 11 2.1 Organization of the dossier 11 2.2 Data directory 12 2.3 Working paper 13 2.3.1 Utilisation of national evaluations 14 CHAPTER 3 15 JMPR EVALUATIONS – REQUIREMENTS AND PRACTICES 15 3.1 Introduction 15 3.2 Identity and physical chemical properties 16 3.2.1 Identity 16 3.2.2 Physical and chemical properties 16 3.3 Metabolism and environmental fate 17 3.3.1 Plant metabolism 21 3.3.2 Rotational crop studies 22 3.3.3 Farm animal metabolism 25 3.3.4 Environmental fate in soil, water and water-sediment systems 26 3.4 Residue analysis 27 3.4.1 Analytical methods 27 3.4.2 Extraction efficiency of residue
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