Transcription

ISSN 0259-2517225FAOPLANTPRODUCTIONAND PROTECTIONPAPERISBN 978-92-5-10913-37 8 9 2 5 1ISSN 0259-25170 9 1 3 3 3I5452E/1/03.16FAO9Submission and evaluation of pesticide residues data for estimation of maximum residue levels in food and feedThe first version of this manual on the submission and evaluation of pesticide residues data forestimation of maximum residue levels in food and feed was printed by FAO in 1997 as a workingdocument with the aim of consolidating the procedures used by the FAO Panel of experts onpesticide residues. The FAO Manual was revised in 2002 and in 2009 incorporated additionalinformation from the JMPR Report of 1997-2009. Since then there have been many developments inthe scientific evaluation process of the Joint Meeting on Pesticide Residues (JMPR), administered byFAO and the World Health Organization. The present manual incorporates all relevant informationand principles that are currently used by the JMPR to estimate maximum residue levels (MRLs),supervised trials median residue (STMR) values and dietary risk from pesticide residues. The manualwill constantly be revised and updated in the light of experience gained and developments inresidue data evaluation. Its aim is also to improve communication between the Codex Committeeon Pesticide Residues (CCPR) and its member countries and other participants in the CCPR and toexplain the procedures being adopted by the FAO Panel of the JMPR.Submission and evaluationof pesticide residues datafor the estimation ofmaximum residue levelsin food and feedThird editionPESTICIDERESIDUES225

Front Grey Page Manual 2015 copy.pdf 1 22/01/2016 12:12:53Submission and evaluationof pesticide residues datafor the estimation ofmaximum residue levelsin food and feedThird editionCMYCMMYCYCMYKFOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONSRome, 2016FAOPLANTPRODUCTIONAND PROTECTIONPAPER225

The designations employed and the presentation of material in this information product do not imply theexpression of any opinion whatsoever on the part of the Food and Agriculture Organization of the UnitedNations (FAO) concerning the legal or development status of any country, territory, city or area or of itsauthorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companiesor products of manufacturers, whether or not these have been patented, does not imply that these havebeen endorsed or recommended by FAO in preference to others of a similar nature that are notmentioned.The views expressed in this information product are those of the author(s) and do not necessarily reflect theviews or policies of FAO.ISBN 978-92-5-109133-3 FAO, 2016FAO encourages the use, reproduction and dissemination of material in this information product. Exceptwhere otherwise indicated, material may be copied, downloaded and printed for private study, research andteaching purposes, or for use in non-commercial products or services, provided that appropriateacknowledgement of FAO as the source and copyright holder is given and that FAO’s endorsement ofusers’ 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 bemade via www.fao.org/contact-us/licence-request or addressed to [email protected] information products are available on the FAO website (www.fao.org/publications) and can bepurchased through [email protected]

FAO Manual on the Submission and Evaluation of Pesticide Residues DataPREFACEThe basic principle of the work undertaken by members of the Joint FAO/WHO Meeting onPesticide Residues (JMPR), is the continuous evaluation of new scientific developments andguidance documents. In considering such initiatives, the members draw on their ownexperience 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 recommendationsto the Codex Committee on Pesticide Residues (CCPR) and Codex Members in order toensure consumer safety and facilitate international trade.The 3rd edition of the FAO Manual incorporates the current working principles applied by theFAO 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 onthe:x incorporation of the ‘Risk analysis principles applied by the CCPR’ in the workingprocedures of the JMPR;x method validation and performance criteria of analytical methods applied in supervisedtrials, including sample preparation and processing, and considering residues belowLOQ;x risk assessment of metabolites and degradates of pesticides by applying the thresholdtoxicological 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 OECDMRL 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 intakeof pesticide residues;The reporting of supervised trials are assisted with the attached electronic versions of theExcel templates and spreadsheets to the Manual that can be downloaded from the FAOHomepage map/theme/pests/jmpr/jmpr-docs/en/The JMPR will continue its activities with respect to considering and refining assessmentmethodologies to ensure the best use is made of all available information. Wheremodifications to current practices are deemed warranted, the basis for such changes will beelaborated in the annual JMPR Reports. The reader is advised to consult the Reports forinformation on any such new developments. heme/pests/jmpr/jmpr-rep/en/).iii

FAO Manual on the Submission and Evaluation of Pesticide Residues DataACKNOWLEDGEMENTProfessor Árpád Ambrus, a FAO temporary advisor, prepared the manuscript for the thirdedition.During past years the Members of the FAO Panels took active part in the elaboration of theworking principles, which are included in this and the previous editions.Mrs. Trijntje van der Velde-Koerts proposed substantial structural changes of the 3rd editionof the Manual to improve usability and facilitate the finding of relevant information. ProfessorEloisa 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.YukikoYamada, and Dr Guibiao Ye provided additional suggestions for improving the clarity andrelevance of the text. Dr Mi-Gyung Lee prepared Annex 2 of Appendix X. Mr. ChristianSieke provided the Excel template for calculation of animal burdenDr Yong Zhen Yang, FAO Joint Secretary, contributed with useful comments and suggestionsto 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 ofthe Manual layout.iv

FAO Manual on the Submission and Evaluation of Pesticide Residues APTER 1INTRODUCTION1.1 Scope of this manual1.2 Historical background1.3 The object of the work of JMPR1.4 The JMPR assessment process1.5 Data and information required for JMPR evaluations1.5.1 New and periodic reviews1.5.1.1 New and existing MRLs1.5.1.2 GAP information.1.5.1.3 Supporting studies.1.5.2 Re-evaluations111134668999CHAPTER 2PREPARATION OF DATA DOSSIERS FOR THE CONSIDERATION OF THE FAO PANEL OFJMPR2.1 Organization of the dossier2.2 Data directory2.3 Working paper2.3.1 Utilisation of national evaluations1111121314CHAPTER 3JMPR EVALUATIONS – REQUIREMENTS AND PRACTICES3.1 Introduction3.2 Identity and physical chemical properties3.2.1 Identity3.2.2 Physical and chemical properties3.3 Metabolism and environmental fate3.3.1 Plant metabolism3.3.2 Rotational crop studies3.3.3 Farm animal metabolism3.3.4 Environmental fate in soil, water and water-sediment systems3.4 Residue analysis3.4.1 Analytical methods3.4.2 Extraction efficiency of residue analytical methods3.4.3 Stability of pesticide residues in stored analytical samples3.5 Use pattern3.5.1 Periodic review compounds undergoing re-registration by national authorities3.5.2 Presentation of GAP information3.6 Residues resulting from supervised trials on crops3.6.1 Planning and implementation of supervised trials3.6.1.1 Number of trials3.6.1.2 Consideration of various types of formulations and derivatives of active ingredient3.6.2 Sampling and analytical methods3.6.3 Reporting the results of trials3.7 Fate of residues in storage and processing3.7.1 Information and data from trials on stored products3.7.2 Fate of residues in food processing3.7.2.1 Guidelines for the conduct of processing studies on the nature of the 48495051515255v11

FAO Manual on the Submission and Evaluation of Pesticide Residues Data3.7.2.2 Test conditions for processing procedures3.8 Residues in animal commodities3.8.1 Animal feeding study3.8.2 Documentation of animal feeding studies3.8.2.1 Nature of fat samples in studies with fat-soluble compounds3.8.3 Direct treatment of animals or premises3.9 Residues in food in commerce and at consumption3.9.1 Data requirements for EMRL estimation3.9.2 Submission of information for estimation of MRLs of pesticide residues in/on spices3.9.2.1 Submission of monitoring data3.9.2.2 Designing of selective field surveys and reporting data for obtaining residue data in/onspices3.10 National residue definitionsCHAPTER 4DEFINITION OF RESIDUES4.1 Definition of residues4.1.1 General principles4.1.2 Dietary risk assessment of metabolites and degradates of pesticides4.1.3 Principles followed in defining residues for enforcement4.2 Fat APTER 581JMPR PRACTICES IN ESTIMATION OF MAXIMUM RESIDUE LEVELS, AND RESIDUESLEVELS FOR CALCULATION OF DIETARY INTAKE OF PESTICIDE RESIDUES815.1 Introduction815.2 Comparability of supervised trial conditions to GAP825.2.1 General principles825.2.2 Application rate835.2.3 Pre-harvest interval845.2.4 Number of treatments865.2.5 Formulation865.2.6 Interpretation tables for supervised trials data875.3 Definition of independent supervised residue trials875.4 Selection and reporting of residue data885.4.1Treatment of apparent outliers895.4.2 Residues below LOQ895.4.3 Rounding of residue values895.5 Combining of data populations895.5.1 Estimation of group maximum residue levels STMR and HR values for plant commodities 905.5.2 Combining residue data from supervised trials conducted in different locations955.6 Estimation of maximum residue levels in plant commodities965.6.1 Information considered in estimating maximum residue levels965.6.2 Principles of selection of residue data for estimation of MRLs985.7 Specific considerations in estimating maximum residue levels for individual commodities995.7.1 Fruits and vegetables995.7.2 Grains and seeds995.7.3 Forage and fodder995.8 Extrapolation of residue data to minor crops1005.9 Statistical methods for estimation of MRLs for plant commodities based on supervised trial data1015.10 Processed commodities1025.10.1 General principles1025.10.2 Special considerations for dried chili peppers1035.11 Estimation of maximum residue levels based on monitoring data1035.11.1 Estimation of maximum residue levels, HR and STMR values in spices1035.11.2 Estimation of extraneous maximum residue levels1055.12 Estimation of maximum residue levels, STMR and HR values for commodities of animal origin1065.12.1 Residues arising from consumption of feed items107vi

FAO Manual on the Submission and Evaluation of Pesticide Residues Data5.12.1.1 Use of the calculated dietary burdens to estimate maximum residue levels, and STMR andHR values for commodities of animal origin1125.12.2 Residues arising from direct application to farm animals1145.12.3 Reconciliation of MRL recommendations resulting from direct treatment and from residues inanimal feed1145.12.4 Maximum Residues in Animal products1145.13 Expression of maximum residue limits (MRLs)1175.13.1 Expression of MRLs at or about the LOQ1185.14 Recommendations for maximum residue limits1215.14.1 Recommendation of temporary MRLs1215.14.2 Guideline Levels121CHAPTER 6ESTIMATING DIETARY INTAKE OF PESTICIDE RESIDUES6.1 Background6.2 Long-term dietary intake6.3 Short-term dietary intake6.4 Acute reference dose6.5 IESTI tables6.5.1 Animal commodities IESTI calculations6.6 Handling of cases where JMPR estimates of dietary intake exceed the ADI or ARfD123123123124127129130132132CHAPTER 7USE OF JMPR RECOMMENDATIONS BY REGULATORY AUTHORITIES7.1 Introduction7.2 Safety assessment of pesticides7.2.1 Relevance of pesticide specifications for JMPR evaluations7.3 Residue studies and recommended MRLs7.4 Interpretation of residue analytical results in comparison with MRLsREFERENCES135135135135136136137141Appendix IABBREVIATIONS USED IN THE TEXT147147Appendix IIGLOSSARY OF TERMS149149Appendix IIISTANDARD TWO LETTERS CODE FOR PESTICIDE FORMULATIONS157157Appendix IVMRL PERIODIC REVIEW PROCEDURE BY CCPR159159Appendix VRECOMMENDED SAMPLING METHODS FOR SUPERVISED FIELD TRIALS1. General recommendations2. Contamination3. Control samples4. Sampling in decline studies and at normal harvest time5. Sampling animal tissues, milk and eggs6. Sampling processed commodities7. Sampling stored commodities8. Sample size reduction9. Sample packing and storage165165165166167167172174174175175Appendix VI179PORTION OF COMMODITIES TO WHICH CODEX MAXIMUM RESIDUE LIMITS APPLY AND179WHICH IS ANALYSED22Appendix VII187

FAO