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FAO manual on
the submission and evaluation of pesticide
residues data for the estimation of maximum
residue levels in food and feed
Food and Agricultural Organization of the United Nations
Rome, 1997
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PREFACE
The “Joint Meeting on Pesticide Residues” (JMPR) is an expert ad hoc bodyadministered jointly by FAO and WHO. The JMPR evaluates pesticide residue andtoxicology data for estimation of maximum residue levels and Acceptable Daily Intakes(ADIs). It is composed of two groups, the FAO Panel on Pesticide Residues in Food andthe Environment which estimates maximum residue levels and the WHO CoreAssessment Group (formerly WHO Expert Group on Pesticide Residues) whichestimates ADIs and identifies risks to organisms in the environment.
The JMPR has evaluated pesticides over the last 30 years with the aim ofestimating the maximum residue levels in food and feed which are likely to result fromlegally permitted uses of pesticides. These estimates are the basis for establishinginternational Maximum Residue Limits (MRLs) in food and feed commodities moving ininternational trade.
Both the FAO Panel and the WHO Core Assessment Groups have appliedconsistent scientific principles and data requirements in their respective areas over theyears, although elements of these have gradually been revised to higher standards, as hasalso occurred at the national level. The formats of the evaluations (monographs) havealso been gradually revised.
The aims of the FAO Manual are to:• clarify, update and consolidate the procedures used by the FAO Panel for the
evaluation of experimental data and related information;• improve transparency of the work of the FAO Panel• define and provide guidance on the type, amount, quality and format of data
submissions required for the estimation of maximum residue levels on which theCodex MRLs are based;
• facilitate the acceptance of Codex MRLs by the governments and their use within theWTO Agreement on the Application of Sanitary and Phytosanitary Measures;
• serve as a source of information and instruction for all those directly involved in theactivities of the FAO Panel of the JMPR, including data submitters and FAO Paneldata reviewers; and
• assist member countries in evaluating residue data for the registration of pesticidesand in developing their national evaluation systems.
The present FAO Manual incorporates all relevant information and principleswhich are currently used by the JMPR to estimate maximum residue levels andsupervised trials median residue levels. Because guidelines by their very nature aresubject to revision with time in order to accommodate new scientific developments andstandards, users of these guidelines are advised to keep abreast of these changes byreading future JMPR reports where such updates are recorded. The FAO Manual will beupdated in the future in the light of experience gained and further developments inresidue data evaluation.
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The FAO Manual is referred to in the text as “the Manual”.
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ACKNOWLEDGEMENT
The preparation of this Manual was initiated by the FAO Secretary to the JMPR and workwas started by Dr. A. J. Pieters and Prof. A. F. H. Besemer, and then continued by Dr. K.Voldum-Clausen.
Based on the recommendations of the members of the FAO Panel of the 1996JMPR, the previous text of the manual was revised by Dr. Árpád Ambrus in close co-operation with the members of the Panel and invited experts, namely: Dr. Angie V. Adam,Dr. Ursula Banasiak, Mr. Stephen Crossley, Dr. Eloisa Dutra Caldas, Mr. DenisHamilton, Mr. Fred Ives, Ms Elena Masoller, Dr. Tsuyoshi Sakamoto and Dr. YukikoYamada.
All contributions to the preparation of the Manual are highly appreciated andacknowledged.
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CONTENTS
1 INTRODUCTION.................................................................................................................. 1
1.1 Historical background..................................................................................................... 1
1.2 The object of the work of JMPR.................................................................................... 3
1.3 The JMPR assessment process.................................................................................... 3
2. SELECTION OF COMPOUNDS FOR EVALUATION .................................................... 6
2.1 Selection of new compounds ........................................................................................... 6
2.2 Periodic review of old compounds .................................................................................. 9
2.3 Re-evaluation of compounds .......................................................................................... 9
3. DATA AND INFORMATION REQUIRED FOR JMPR EVALUATIONS................. 10
3.1 New and periodic review compounds ........................................................................... 103.1.1 Identity ...................................................................................................................... 113.1.2 Metabolism and environmental fate ......................................................................... 133.1.3 Methods of residue analysis and stability of pesticide residues in stored
analytical samples................................................................................................. 143.4 Use pattern.................................................................................................................... 163.1.4.1 Explanatory notes for presenting GAP information............................................. 213.1.5 Residues resulting from supervised trials ................................................................ 253.1.5.1 Information and data from livestock transfer (feeding) and external
animal treatment studies ...................................................................................... 303.1.5.2 Information on veterinary uses .............................................................................. 333.1.6 Fate of residues in storage and processing .............................................................. 333.1.6.1 Information and data from trials on stored products............................................ 333.1.6.2 Information and data on residues in processed food............................................ 343.1.6.3 Information and data on residues in the edible portions of food
commodities .......................................................................................................... 353.1.7 Residues in food in commerce and consumption..................................................... 353.1.8 National Maximum Residue Limits .......................................................................... 35
3.2 Reconsideration of previous recommendations ......................................................... 35
4. PREPARATION OF DATA SUBMISSIONS FOR THE CONSIDERATIONOF THE FAO PANEL OF JMPR ............................................................................ 38
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4.1 Standardised format of the directory ........................................................................... 39
4.2 Standardised format of the working paper/monograph.............................................. 394.3 Organization of the submission .................................................................................... 40
5. THE JMPR PRACTICE IN ESTIMATING MAXIMUM RESIDUES LEVELSAND PROPOSING MAXIMUM RESIDUE LIMITS .......................................... 43
5.1 Evaluation of available information ............................................................................. 435.1.1 Chemical and physical properties of a pesticide ...................................................... 435.1.2 Metabolism and degradation of pesticides after application on plants,
animals and soil..................................................................................................... 445.1.3 Information received on Good Agricultural Practices............................................. 455.1.4 Residue data .............................................................................................................. 465.1.4.1 Results of supervised trials .................................................................................... 465.1.4.1 Results of selective surveys................................................................................... 465.1.5 Processing studies...................................................................................................... 465.1.6 Results of national monitoring programmes............................................................. 48
5.2 Re-evaluation of compounds ........................................................................................ 48
5.2.1 Re-evaluation of additional information ................................................................... 485.2.2 Re-evaluation of compounds being in the CCPR periodic review
programme ............................................................................................................ 48
5.3 Definition of residues.................................................................................................... 505.3.2 Principles followed in defining residues for MRLs .................................................. 52
5.4 Estimation of maximum residue levels ....................................................................... 565.4.1 Specific considerations in estimating maximum residue levels ............................... 595.4.2 Estimation of group maximum residue levels ........................................................... 625.4.3 Estimation of extraneous residue levels (ERL) ....................................................... 65
5.5 Expression of Maximum Residue Limits ................................................................... 685.5.1 Expression of Maximum Residue Limits at or about the limit of
determination........................................................................................................ 69
5.6 Recommendations for Maximum Residue Limits....................................................... 715.6.1 Recommendation of Temporary MRLs ................................................................... 725.6.2 Estimation of Guideline Levels ................................................................................ 72
6. ESTIMATION OF RESIDUE LEVELS FOR CALCULATION OF DIETARYINTAKE OF PESTICIDE RESIDUES .................................................................... 74
6.1 Guidelines for predicting dietary intake ..................................................................... 74
7. USE OF JMPR RECOMMENDATIONS BY REGULATORY AUTHORITIES ......... 82
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7.1 Safety assessment of pesticides................................................................................... 82
7.2 Residue studies and recommended MRLs ................................................................. 83
7.3. Interpretation of residue analytical results in comparison with MRLs .................... 83
8. REFERENCES .................................................................................................................... 86
APPENDICES
I. Abbreviations used in the text ...…......................................................................……........75
II. Glossary of terms ......................….............................................................................…......76
III.CIPAC Codes for pesticide formulations ................................….................................…...83
IV.MRL Periodic Review Procedure by CCPR ............................…….............................….84
V.Recommended Sampling method for Supervised Field Trials.......….................................. 88
VI. Portion of Commodities to which Codex MRLs apply ................... ...........................102
VII.Standardised format for organising the Data Directory (index) of
information to be submitted for evaluation ..............................................................…...116
VIII.Pesticide information for CCPR Working Group on Priorities.............................…..... 119
IXMaximum proportion of agricultural commodities in animal feed ....................................120
X. JMPR Manual for FAO Panel Members .........................................................................133
SUBJECT INDEX ………………………………………………………………………159
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1 INTRODUCTION
The Manual gives the historical background of the operation of the JMPR and describesthe object of the work, the procedures involved in selection of compounds, the datarequirements for estimating maximum residue levels and the principles followed in theevaluation of experimental results and information provided.
The definition of terms used in this Manual is given in Appendix II. Thedocuments which were used for the preparation of the Manual are listed under“References.”
1.1 Historical background
The rapidly growing use of pesticides in agriculture after World War II gave rise toregulation by governments of the sale and use of pesticides to prevent chemicals withunacceptable properties being introduced onto the market. The use of chemicals wasregulated in order to protect the users of pesticides, the consumers of treated foodstuff,domestic animals and, at a later stage, the environment.
For this purpose governments requested manufacturers and other data submittersto submit information on the properties of their products and on their intended uses. Asdifferences arose among countries on the extent and scope of data to be supplied,international organizations initiated attempts to harmonise requirements.
In April 1959, the Director-General of FAO convened a Panel of Experts on theUse of Pesticides in Agriculture in Rome. This panel considered various problemsconnected with the use of pesticides. With regard to pesticide residues the panelconcluded that governments should be urged to include, in addition to public healthauthorities, bodies involved in agricultural pesticide and plant and animal protectionwhich advise on regulations to control pesticide residue levels. Studies should beintensified on problems involving the analysis of pesticide residues in or on foodstuffs.Furthermore, the panel recommended studies to be undertaken jointly by FAO and WHOon the hazards arising from pesticide residues in and on food and feedstuffs, on theestablishment of principles governing the setting-up of pesticide tolerances, on thefeasibility of preparing an International Code for toxicological data and residue datarequired to achieve the safe use of a pesticide.
A joint meeting of the FAO Panel of Experts and the WHO Expert Committee onPesticide Residues was held in Rome in October 1961 to implement thisrecommendation. In his letter to the members of this meeting, the Directors-General ofFAO and WHO stated that the meeting should consider, among other matters, principlesfor establishing tolerances for pesticide residues in food. The meeting developeddefinitions for a number of terms, which laid the foundation for the current “Glossary ofTerms” used by the JMPR. Although the meeting developed the concept of a
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"permissible level", calculated from the Acceptable Daily Intake (ADI), the food factorand the average weight of the consumer, it accepted at the same time that the "tolerance",which is comparable with the present MRL, be estimated "...taking into account the rangeof residues actually remaining when the food is first offered for consumption (followingGood Agricultural Practice)...". The meeting recommended to the Directors-General ofFAO and WHO the promotion of studies on methods for carrying out toxicity studies andtheir evaluation, leading to ADI and on collaborative studies, leading to internationallyacceptable analytical methods for pesticide residues. No conclusion was drawn withregard to the estimation of internationally acceptable tolerances. This might be ascribedto the meeting's opinion that different countries may establish different tolerances forthe same pesticide on the same food, but that this would not impede the free movementof that food in international trade as long as the permissible level was not exceeded.
In November 1962, an FAO Conference on Pesticides in Agriculture was held inRome. The Conference expressed its concern that differences in residue tolerancesexisted not only among countries of different regions but also among those of the sameregion. FAO was strongly urged to investigate the reasons for these differences and, ifpossible, find ways to harmonise them. Consequently, the Conference recommended thatthe proposed Working Party on Pesticide Residues should pay particular attention to (a)the toxicity of pesticides and test methods; (b) the possible unification of tolerances;(c) co-ordination of methods of analysis; (d) surveys for collecting residue data; and (e)the establishment of a list of pesticides to which interested governments should giveresearch priority. The Conference supported the principle that the amount of pesticideresidue in food should not exceed that resulting from "Good Agricultural Practices" butrecommended that governments should not adopt residue tolerances before internationalagreement on this subject had been achieved.
In a Joint Meeting of the FAO Committee on Pesticides in Agriculture and theWHO Expert Committee on Pesticide Residues held in Geneva from 30 September to 7October 1963, the toxicological properties of a number of pesticides were studied forthe first time and a few ADIs established. No developments took place in the area ofresidues.
The first meeting of the FAO Working Party on Pesticide Residues,recommended by the 1962 FAO Conference, took place in December 1963. TheWorking Party studied ways and means to arrive at recommendations for levels ofresidue tolerances. The following were considered essential:
(a) residue levels resulting from Good Agricultural Practice (GAP ) should be obtainedby FAO from governments and pesticide manufacturers. These data should beconsidered by the FAO Working Party on Pesticide Residues. After considerationof the ADI and of the national nutritional patterns as stated in the FAO FoodBalance Sheets, the Working Party would propose tolerances for residues onindividual crops for consideration by governments and by the Expert Committee onPesticide Residues of the Codex Alimentarius Commission;
(b) residues found in surveys of marketed commodities;
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(c) ADIs to be estimated by joint meetings of the WHO Committee on PesticideResidues and the FAO Committee on Pesticides in Agriculture;
(d) national nutritional patterns; and(e) acceptable analytical methods for residues. These methods should also be adopted
by the Pesticide Committee of the Codex Alimentarius.
For pesticides where an ADI had still to be estimated the Working Party wouldpropose provisional tolerances. It was stated that the Expert Committee on PesticideResidues of the Codex Alimentarius Commission (the predecessor of CCPR) shouldmeet only after the FAO Working Party had collected and evaluated the required data andmade its proposals for tolerances. This procedure would enable the Codex Committee,composed of government representatives, to act on the basis of technical informationdeveloped by specialists acting in their individual capacities.
1.2 The object of the work of JMPR
The current JMPR comprises the WHO Toxicological and Environmental CoreAssessment Groups and the FAO Panel of Experts on Pesticide Residues in Food and theEnvironment. The WHO Toxicological Core Assessment Group is responsible forreviewing pesticide toxicological and related data and estimating no observed adverseeffect levels (NOAELs) of pesticides and Acceptable Daily Intakes (ADI) of theirresidues in food for humans. In addition, as data and circumstances dictate, the Groupestimates acute reference dose (acute RfD) and characterises other toxicological criteriasuch as non-dietary exposures. The WHO Environmental Core Assessment Group’s roleis to identify risks to organisms in the environment.
The FAO Panel is responsible for reviewing pesticide use patterns (GAPs), dataon the chemistry and composition of pesticides, environmental fate, metabolism in farmanimals and crops, methods of analysis for pesticide residues and for estimatingmaximum residue levels and supervised trials median residue values (STMRs) ofpesticides in food and feed commodities. The toxicity of the active ingredient and itsmetabolites, evaluated by the WHO Toxicological Core Assessment Group, is taken intoconsideration in deciding if residues may or may not give rise to problems of publichealth. The maximum residue levels are recommended to the Codex Committee onPesticide Residues (CCPR) as suitable for consideration as Codex Maximum ResidueLimits (Codex MRLs) to be adopted by the Codex Alimentarius Commission (CAC).
The monographs prepared by the FAO Panel contain all the information which wasused to estimate maximum residue levels. In addition, they give supporting informationsuch as the physical and chemical characteristics of the pesticides, distribution ofresidues in various tissues, storage stability of residues, effect of processing andcooking on residue levels and fate in the environment.
1.3 The JMPR assessment process
This Manual is limited to the procedure followed by the FAO Panel of Experts.
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The evaluations carried out by the JMPR comprise three main categories:• review of new compounds (compounds evaluated by the JMPR for the first time);• review of compounds under the periodic review programme;• re-evaluation of new information relating to compounds other than new or periodic
review chemicals.
The principles of evaluation of new compounds and compounds under the periodicreview programme are very similar and follow the order of subjects described under DataRequirements (Section 3.1). Re-evaluation of a compound is carried out when newinformation related to its use and residue levels becomes available (e.g. change in or newuse patterns, data on metabolism, residue behaviour, etc.). The re-evaluation often dealswith and clarifies a single question raised by the Codex Committee on PesticideResidues. The scope and depth of periodic review and re-evaluations are substantiallydifferent, and they are explained in section 5.2.2. To make a clear distinction between theperiodic review and re-evaluation of compounds, the latter is often referred to by theFAO Panel as normal re-evaluation.
The agenda of the meetings is decided by the Joint Secretaries of FAO and WHO,based on the priority list proposed by the Codex Committee on Pesticide Residues andapproved by CAC, and on the information on availability of sufficient data for evaluation.
Member countries, industry and other data submitters are requested to supply theFAO Panel with all relevant information on identity, metabolism and environmental fate,methods of residue analysis, use patterns (registered and officially authorised uses),supervised residue trials (including field trials and animal transfer studies), fate ofresidues in storage and processing, residues in food in commerce or at consumption, andnational maximum residue limits.
The FAO Joint Secretary of JMPR assigns the compounds for review to themembers of the FAO Panel and informs data submitters accordingly. The companiessubmit the required information to the Panel member, who performs the evaluation ofthe company’s data together with the information received from the member countriesthrough the FAO Joint Secretary before the meeting, and prepares (i) the draftMonograph containing the summarised experimental data and relevant information and(ii) the draft Appraisal containing the evaluation of the results and draftrecommendations.
During the Joint Meeting the FAO Panel discusses the evaluations and agrees onthe recommendations. The FAO and WHO Expert Groups co-ordinate their activities and,as needed, discuss chemical and toxicological aspects (e.g. metabolism patterns, leveland toxicological significance of metabolites), clarify or resolve problematic issues, andfinally the groups issue a joint Report containing the conclusions and recommendationsof the Meeting.
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A short introduction to the assessment process carried out by the FAO Panelfollows. A more detailed account of each stage of the process is given in succeedingsections.
In the process of evaluation of a new compound (or periodic review compound), awide range of information and experimental data are reviewed.
The physical and chemical properties of the active ingredient, the metabolism anddegradation of the compound in animals, plants, soil and water are studied to determinethe composition and distribution of residues. Based on this information, and taking intoaccount the available analytical methodology as well as the toxicological significance ofmetabolites and degradation products, the Panel recommends the definitions of residuesfor enforcement purposes and for dietary intake calculations.
It is emphasised that residues deriving from supervised field trials can only beused for estimating maximum residue levels if the trial conditions can be matched withrelevant national GAPs. The maximum residue level estimates are based on alreadyapproved national uses (national GAP), which lead to the highest residue populations inthe portion of commodities to which Codex MRLs apply (Appendix VI). The JMPR doesnot approve uses.
The maximum residue levels for residues in commodities of animal origin aremainly estimated taking into consideration the results of animal transfer (feeding)studies and residues occurring in feed items and, to a lesser extent, the informationobtained from animal metabolism studies. MRLs for animal commodities may alsorelate to the residues arising from direct animal treatments.
The analytical methods with accompanying chromatograms and information onstability of residues during sample storage are evaluated to assess the reliability of trialdata and to estimate Limits of Determination of residues which can be realisticallyachieved in regulatory laboratories.
The fate of residues during processing and cooking, as well as residues in theedible portion, are taken into consideration in the estimation of dietary intake.
The results of national monitoring programmes and total diet studies provideuseful information, especially for dietary intake estimations, on residues occurring underpractical use conditions. Furthermore, the estimation of extraneous residue levels(ERLs, see Section 5.4.3) is based on monitoring data.
The fate of residues in the environment is evaluated to assess the possibility ofuptake of residue by the crop (e.g. from a soil treatment) and by following crops, and thecontamination of the environment by persistent residues.
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2. SELECTION OF COMPOUNDS FOR EVALUATION
2.1 Selection of new compounds
The Secretariat of the Joint FAO/WHO Food Standard Programme regularly invitesmember countries of CAC to propose pesticides to be added to the Codex Priority Listof Pesticides for subsequent recommendation to the JMPR for evaluation. The proposalsare considered by CCPR at the successive meeting. Based on the information received,CCPR prepares the priority list of pesticides and the tentative lists of compounds to beconsidered by the JMPR at its subsequent meetings.
2.1.1 Procedure for proposing pesticides for Codex Priority List
The procedure has recently been described in the Circular of Codex Secretariat, CL1996/35-PR. The procedure to be followed when proposing pesticides for inclusion inthe Codex Priority List is given below. The form in which information is to be providedis given in Appendix VIII.
1. Criteria for Inclusion of Compounds in the Priority List
Before a pesticide can be considered for the Priority List it:
(a) must be available for use as a commercial product; and(b) must not have been already accepted for consideration.
To meet the criteria for inclusion in the priority list, the use of the pesticidemust: give rise to residues in or on a food or feed commodity moving ininternational trade whose presence is (or may be) a matter of public healthconcern and/or create (or have the potential to create) problems in internationaltrade.
2. Criteria for Selecting Food Commodities for which Codex MRLs or EMRLs shouldbe Established
The commodity for which the establishment of a Codex MRL or EMRL is soughtshould:
(a) form a component of international trade;(b) represent a significant proportion of the diet; and(c) contain pesticide residues as evidenced in monitoring programmes.
3. Procedures to be followed for Commodity/Pesticide Combinations which meet theSelection Criteria
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Governments are recommended to:
check if the pesticide is already in the Codex system.NOTE: Pesticide/commodity combinations which are already included inthe Codex system or under consideration are found in a working documentprepared for and used as a basis of discussion by each Session of the CodexCommittee on Pesticide Residues. Consult the most current revision of thedocument to see whether or not a given pesticide has already been considered.
If "YES", - proceed to section (b) below,If "NO ", - proceed as follows in (a):
(a) (i) consult the manufacturer(s) regarding the existence of sufficienttoxicological, residue and critical supporting data and confirm that themanufacturer(s) would be willing to submit data to the JMPR, and in whichyear, and
(ii) submit the information to the person designated by the CCPR using theform given in Appendix VIII.
(b) where the pesticide has already been evaluated by the JMPR and MRLs, ERLs orGLs have been established, two situations may arise:
(i) interest exists in proposing MRLs for a new commodity. Consult the mostrecent working document containing all MRLs to ensure that MRLs havenot already been established or considered for the commodity/pesticidecombination. Where interest exists in developing data for a newcommodity, governments are urged to discuss with industry the possibilityof collaborative programmes, e.g., manufacturers may be willing to analysesamples from supervised residue trials conducted in accordance with FAOGuidelines on Pesticide Residue Trials to Provide Data for the Registration ofPesticides and for the Establishment of Maximum Residue Limits. Proposalsfor new commodity/pesticide combinations and new residue data may besubmitted directly to the FAO Joint Secretary of the JMPR without theneed for submissions according to Appendix VIII, as described in (a)above..
(ii) in those cases where additional toxicological data have become available,governments may wish to propose a pesticide for re-evaluation. The formgiven in Appendix VIII should be used for this purpose. Where a seriouspublic health concern exists in relation to a particular pesticide,governments should notify the WHO Joint Secretary of the JMPRpromptly and provide appropriate data.
4. Copies of Correspondence
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All communications to the various persons mentioned above should be copied tothe Chairman of the CCPR. Communications on 3(a) and 3(b) above should also becopied to the designated person without enclosing the detailed toxicological or residuedata.
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5. Data Deadline
The above procedures relate mainly to the establishment of Codex Priority Lists.Once the agenda of the JMPR has been agreed, the Secretariat of the JMPRrequests that detailed residue and toxicological data be submitted by a stateddeadline. Normally directories or lists of studies to be submitted to the FAOPanel are required by 30 November of the year before the scheduled review. Theactual data submissions and working paper are expected no later than 28 Februaryof the year of the scheduled FAO Panel review. Less substantial submissions tosupport FAO Panel consideration of questions from a CCPR meeting maynormally be accepted by 31 May of the year in which the issue will beconsidered. The agreed Priority Lists indicating the pesticides scheduled to beevaluated by the JMPR are attached to the Reports of the Sessions of the CCPRand distributed to Member Countries.
6. Industry Contact Points
Further information about industry contact points on specific chemicals isavailable from the Technical Director of Global Crop Protection Federation(formerly GIFAP) 25, Avenue de Beaulieu, Box 25, B-1180 Brussels, Belgium.
2.2 Periodic review of old compounds
Since the use conditions of the compounds may change with time, the Codex MRLsestablished several years ago may not reflect current use patterns. Furthermore, some ofthe old toxicological studies and residue trials may not meet the current standards.Within the CCPR, and also within the JMPR, there has been concern with respect tomaintaining CXLs that may no longer reflect the current information. Consequently, theperiodic review of old compounds has been initiated by the CCPR and the periodicreview procedure has been agreed (Appendix IV).
2.3 Re-evaluation of compounds
After a compound has been evaluated by the JMPR, changes in the authorised uses mayoccur or new information on the properties of the pesticide may become available whichaffect the recommended MRLs or require the estimation of new maximum residue levelsfor the additional commodities.
Furthermore, the CCPR may refer certain recommendations back to the JMPRfor clarification or reconsideration in the light of the comments received from membercountries.
In both cases the compound is re-evaluated by the JMPR at subsequent meetings.
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3. DATA AND INFORMATION REQUIRED FOR JMPR EVALUATIONS
The JMPR is not a Regulatory Body and therefore cannot “require” (in the strict sense ofthe word) submission of data. However, it can and does refrain from estimatingmaximum residue levels when data are inadequate. In addition, the JMPR publishes list ofthose data which it considers “desirable” when these are found to be lacking orinsufficiently addressed in data submissions.
3.1 New and periodic review compounds
The data and information needed for the evaluation of pesticide residues of newcompounds and compounds evaluated within the periodic review programme are outlinedin this section.
One objective of the periodic review is to make the best use of the existingdatabase, regardless of the age of the studies. As a result, countries and industry wererequested to provide all relevant information irrespective of whether it had beenpreviously supplied. However, experience has shown that some periodic reviewsubmissions contain data that are of limited use for estimating maximum residue levels.For example:
• Residue data are frequently provided that do not relate to current goodagricultural practice (GAP ) and are not accompanied by adequate details ofthe conduct of the field trial, the handling of the samples or details of theanalysis (including associated recovery data).
• Residue data have been developed with non-selective analytical methods(e.g. colorimetric analysis or bioassay).
• Lack of information on specifics and conditions of sampling, sampletransportation , sample storage and intervals from sampling until storageand storage until analysis.
• Critical supporting studies are frequently not included in the packageprovided. Critical supporting studies include: metabolism, animal transfer,
processing, analytical methods and freezer storage stability studies.
In reviewing the submissions provided for periodic review over the last two years,residue data or studies with obvious deficiencies have been found to be submittedroutinely. The usefulness of such information, even as supplementary data, can be judgedonly on a case-by-case basis when considered in the context of the available database.
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In preparing product monographs (working papers) the data submitters shouldconsider the relevance of residue data in the light of current use practices, residuedefinitions, analytical methods etc., and that only data pertinent to commodities withcurrent or proposed uses should be provided for the consideration of the FAO Panel. Ifcritical supporting studies are not provided, the monograph must include an explanationof why specific critical supporting studies (e.g. processing information) were notprovided. In general, studies which fulfil the requirements of modern nationalregistration systems will generally meet the needs of the JMPR.The headings of this section follow the format of the JMPR evaluations.
3.1.1 Identity
ISO common nameChemical name(IUPAC)(Chemical Abstract)CAS Registry. No.:CIPAC No.:Synonyms:Structural formula:Molecular formula:Molecular weight:
3.1.1.1 Physical and chemical properties
A detailed chemical and physical characterisation of the compound should be provided.This information is included for new compounds and those undergoing re-evaluation aspart of the periodic review programme. It serves as guidance for the interpretation ofavailable test data.
Pure active ingredientAppearance:Vapour pressure: ( in mPa at stated temperature)Melting point:Octanol/water partition coefficient:Solubility: ( Water and organic solvents at stated temperatures)Specific gravity: (... g/cm3 at ...stated temperature)Hydrolysis:Photolysis:Dissociation constant:Thermal stability:
Technical materialMinimum purity: ( in %)
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Main impurities: ( range of amounts; confidential information will not bepresented as such in the JMPR monographs)
Melting range:Stability:
3.1.1.2 FormulationsList of commercially available formulations.
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3.1.2 Metabolism and environmental fate
Information is required on:Animal metabolismPlant metabolismEnvironmental fate in soilEnvironmental fate in water/sediment systems
The purpose of conducting metabolism studies is to determine the qualitativemetabolic fate of the active ingredient. Many pesticide undergo change during and afterapplication to plants, soil, water and livestock. The composition of the terminal residuemust, therefore, be determined before the residue analytical methodology data can bedeveloped and residues can be quantified. The dose level and criteria for identificationand characterisation of residue components, including non-extractable residues, aresimilar to those described in guidelines of registration authorities.
The information should include documentation on the identity of the metabolitesand the quantities present. Distinction should be made about the presence of metabolitesin the different parts of the plants (surface, leaves, stems and edible root crops), indifferent animal tissues (fat, muscles, kidneys, liver, egg and milk) and in different soiltypes. The rate of the formation and disappearance of metabolites in plant, animals andsoil must also be investigated.
It is emphasised that all data on animal metabolism have to be provided to both theWHO Expert Group and the FAO Panel of Experts. Normally the WHO Panel willinclude detailed discussion on the metabolism of small experimental laboratory animals(e.g. rats, mice, guinea pigs, rabbits, dogs, etc.) in their monographs and the FAO Panelwill include detailed discussion of the metabolism of larger food animals (e.g. cattle,goats, sheep, pigs and chickens) in their monographs. The required data on plantmetabolism should be submitted to the FAO Panel, while the WHO Group wishes toreceive only schemes of plant metabolism.
Farm animal metabolism studies are required whenever a pesticide is applieddirectly to livestock, to animal premises or housing, or where significant residues remainin crops or commodities used in animal feed, in forage crops, or in any plant parts thatcould be used in animal feeds. In addition to the metabolism studies, separate animalfeeding studies (transfer studies) are required for a ruminant and poultry (and sometimespigs) whenever significant residues (>0.1 mg/kg) occur in items of feed for theseanimals and the farm animal metabolism studies indicate that residues may occur abovethe LOD of residue analytical methods carried out with unlabelled compounds (section3.1.5).
Usually the most important metabolism studies are those involving ruminants andpoultry. Normally lactating cows are used but, in the interest of economy, goats areacceptable alternatives. In the case of poultry, chickens are the animals of choice. Exceptin special cases, it is not necessary to carry out metabolism studies with pigs since
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information on metabolism in monogastric animal is available from studies with rats. Ifmetabolism in the rat is different from that in the cow, goat and chicken, pig metabolismstudies may be necessary.
A high percentage of the administered dose as radiolabelled tracer should beaccountable in animal metabolism studies.
Plant metabolism studies are usually required for a minimum of three diverseplants (unless the pesticide is to be used on only one or two crops). If the metabolism inthree diverse (dissimilar) crops is similar, then the metabolism in other crops isnormally assumed to be similar. However, if the metabolism is different in differenttypes of plants, a metabolism study is required for each type of crop groups (e.g. rootvegetables, leafy crops, fruits, pulses and oilseed, cereals) for which use is proposed.
Plant metabolism studies provide information on the approximate level of totalresidues, identify the major components of the total terminal residue, indicate the routeof distribution of residues and its mobility (uptake from soil, absorption by plants orsurface residue) and show the efficiency of extraction procedures for variouscomponents of the residue.
Studies on environmental fate in soil and in water and water/sediment systems arenormally required for all pesticides except those with specific restricted use (e.g. seedtreatment, post-harvest application in storage). The availability of relevant studies isessential for the assessment of the potential for residues in food and feeds.
The FAO Panel does not need data on environmental toxicology, but does needstudies on environmental fate relevant to the potential for uptake of residues by food andfeed crops. The FAO Panel needs to receive the full studies even if some of the data havebeen submitted to the Environmental Core Assessment Group.
The submitted data should include:• physical and chemical properties;• metabolism and degradation in soil, identification of metabolites and
degradation products, and an indication of their levels;• persistence of the parent compound and its metabolites or degradation
products in soil under aerobic and anaerobic conditions;• mobility of the parent compound and its metabolites in soil;• adsorption by various soils;• hydrolysis rate and products;• photolysis on soil and plant surfaces and its products;• crop uptake and bioavailability of parent compound and its major
metabolites;• residues in rotational crops.
3.1.3 Methods of residue analysis and stability of pesticide residues in stored analyticalsamples
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Analytical methods should include:• Specialised methods used in supervised trials and environmental fate
studies which were submitted for evaluation;• Enforcement methods.
Analytical methods are required to determine all residue components needed forthe residue definitions for compliance with the MRL and for estimation of dietary intake.The major residue components should be determined individually as far as technicallypossible.
The individual studies should be summarised and clearly outline the compoundsdetermined, the commodities for which the method is recommended, specificity,repeatability of the method, the limit of determination and the range of residue levelsfor which the method has been validated, the mean recovery and the relative standarddeviation of recoveries at each fortification level including the limit of determination,etc.
Information should be submitted to the JMPR not only on the analytical principlesused in the supervised trials and experiments but also the whole analytical procedure indetail including a precise description of the portion of sample analysed, tests to provethe efficiency of extraction, recoveries at various levels, limits of determination, limitsof detection, chromatograms of samples and controls and a description of how the limitof determination and detection were derived.
When specific techniques and methods have been used to determine residues insupervised trials which are not readily available in average regulatory laboratories(bearing also in mind the laboratories in developing countries), alternative methodssuitable for regulatory control of residues should also be provided. The regulatorymethod should be validated by comparative analyses of samples of typical field treatedcommodities with both methods.
The regulatory method should be preferably a multi-residue procedure even if itsrecovery is not as good as that of a specific individual method as, generally, thelaboratories do not have sufficient capacity to apply individual methods to look forcompounds possibly present. This fact is clearly demonstrated by the published results ofnational monitoring studies which indicate that compounds recoverable with multi-residue procedures are much more frequently analysed than those requiring individualmethods.
In addition to the company methods, published methods suitable for use byregulatory authorities should also be provided. The CCPR may not proceed with an MRLif no published regulatory method is available.
The results of storage stability tests for residues in stored analytical samples ofrepresentative substrates should be provided for samples held in storage before analysis.For plant materials, the number of crops depends on the use of pesticides. Typical
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matrices should be selected to include predominantly water, oil, protein or starch-containing materials. In the case of animal products tissues, milk and eggs should bechosen. The study conditions should reflect those to which the samples from the residuetrials have been subjected. Where sample extracts have been stored for more than 24hours prior to analysis, the stability of residues should be demonstrated with recoverystudies performed under similar conditions.
Storage stability studies are required because many routes of degradation anddissipation can occur, even under cold storage conditions. Although guidance on properstorage is given, e.g. in the FAO Guidelines on Pesticide Residue Trials to Provide Data forthe Registration of Pesticides and Establishment of MRLs, data submissions to the JMPR inthe past frequently did not include these types of study, even when samples were storedfor periods of 6, 8 or 12 months and even longer. The storage stability studies should bedesigned in such a way that the stability of residues in the stored samples can bedefinitely determined. When the analytical method determines a "total residue", storagestability studies should include not only the total residue, but also separate analyses of allcompounds which may be included in the residue definitions. To emphasise theimportance of information on storage stability, monographs now include a new sub-section under “Methods of Residue Analysis entitled Stability of Pesticide Residues inStored Analytical Samples”.
3.1.4 Use pattern
It is essential, that complete current GAP information on pesticides under considerationis always made available to the JMPR. The GAP information should be presented in asystematic manner according to the standardised format(s) given in this Guide. Theformats were developed principally for applications on agricultural and horticulturalcrops; other appropriate formats will need to be used for reporting special GAP data, e.g.post-harvest treatments, seed dressing and animal treatments. The information should bepresented in such a way as to facilitate comparison with supervised trial conditions.
GAP summaries are intended as an aid to the evaluation of submitted data and areto be provided in addition to certified labels. It is emphasised that original labels have tobe provided by the manufacturer(s) (or other data submitters) in addition to the summaryinformation. Furthermore, the original label should be accompanied by an Englishtranslation of the relevant sections if it is printed in a language other than English.
The use patterns should be summarised by the manufacturers from two aspects,(1) biological efficacy and (2) formulation and application. The biological efficacy maybe described by listing the major pests or diseases controlled, or it can be given intabular form. In the latter case, the table (Table 3.1.4.1) should contain the commodities,pests controlled and the growth stage of crop when the application(s) is (are) likely to berequired.
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Information on formulations, application methods and dosage rates should besummarised in tabular form (Table 3.1.4.2.). Specific information relevant to the useaccording to GAP (such as dosage depending on the pest; specified minimum intervalsbetween repeated applications; total amount of active ingredient which may be appliedduring the growing season; restrictions on irrigation or aerial application) should beadded as a comment or footnote(s).
Governments or responsible national organisations are requested to summarisethe GAP information according to Table 3.1.4.3. The entry required under “Country:” isthe name of the country whose GAP is listed in the table, which is not necessarily thesame as that of the country submitting the information. The table should strictly reflectthe information contained on the label. In simple straightforward cases the enclosure oflabels may not required, although it is desirable. However, if the use instructions aremore complicated than can be shown in the table, or if the reviewer cannot determine ifthe use instruction is in terms of spray concentration or application rate, the label isessential. In the case of extensions of use that do not appear on the product label (ie. off-label registrations), a copy of the registration document or its English translation shouldbe provided.
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Table 3.1.4.1. Example for summarising biological efficacy data
Information on pests/diseases controlled by terbufos (JMPR 1989)
Crop Pests/diseases controlled Timing of application(s)Banana Aphids, corm borer, corm
weevil, nematodes2-4 times per year
Cotton Soil pests, wireworms Furrow treatment at plantingPotato Black maize beetle, wireworm Furrow treatment at plantingSugar cane Nematodes, pink spittlebug,
sugarcane froghopper, WestIndian canefly, whitegrubs,wireworm
Furrow treatment, at planting orside dressing, 4 months PHI
Table 3.1.4.2. Example for summarising GAP information
Registered uses of folpet on vegetables and cereals.
Crop Country Form Application 1 PHI, days
ai Method Rate kg ai/ha Spray conc.,
kg ai/hl
Number
Barley France 1.5 21
Beans Greece WP foliar 0.6-1.5 0.1-0.25 3-4 7
Beans Portugal WP foliar 0.13 1-2 7
Beans, green Spain WP foliar 1.6 0.16 21
Brassica vegetables Italy WP foliar 0.35-0.40 10
Lettuce France WP foliar 0.64 21-412
Lettuce Israel3 WP foliar 2.0 weekly 11
Form: formulation; ai: active ingredient content1 g: glasshouse use.2 summer PHI 21 days, winter PHI 41 days.3 proposed registration.Suggested abbreviations for footnotes to the GAP table are:a: aerial application pr: proposed registrationfg: field and glasshouse use st: seed treatmentg: glasshouse use only t: table grapes onlygs: growth stage restriction w: wine grapes onlyPo: post-harvest use
When different formats are used to report GAP data on special uses (e.g. seeddressing, animal treatment, etc.), they should always include details on the followingaspects of the use pattern:
(a) Responsible reporting body
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(b) Pesticide names:ISO-E common name. If other international code names are used, theStandards organisation should be indicated (between brackets), e.g. (BritishStandards Institute: BSI), (American National Standards Institute: ANSI),(Japanese Ministry for Agriculture, Forestry and Fisheries: JMAF).If relevant, in addition proprietary name(s) or trade name(s) can be given.
(c) CCPR number of pesticide, if available(d) Information on the use pattern as described on the approved label. Use rates
and concentrations must be explicitly expressed in terms of active ingredientor product.
Table 3.1.4.3. SUMMARY OF GOOD AGRICULTURAL PRACTICES FOR PESTICIDE USES(Application on agricultural and horticultural crops )
Responsible body for reporting (name, address): Date: ..........................
Pesticide(s) (common name(s)) : Page: ..........................
CCPR No(s). : Country: .....................
Trade name(s) :
Main uses, e.g. insecticide, fungicide :
Use Pattern
1 2 3 4 5 6 7 8 9
Crop and/or
situation (a)
F
or
Pest or group
of pests)
Formulation Application Application rate
per treatment
PHI
(days)(k)
Remarks: (1)
G
(b)
controlled
(c
Type
(d-f)
Conc. of
ai (i)
method, kind
(f-h)
growth
stage (j)
number (range) kg ai/hl water l/ha kg ai/ha
Explanatory notes for Table 3.1.4.3:(a) In case of group of crops the Codex classification should be used(b) Outdoor or field use (F), or glasshouse application (G)(c) e.g. biting and sucking insects, soil borne insects, foliar fungi(d) e.g. wettable powder (WP), emulsifiable concentration (EC), granule (GR)(e) Use CIPAC/FAO Codes where appropriate(f) All abbreviations used must be explained(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench(h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants(i) g/kg or g/l(j) Growth stage at last treatment(k) PHI = Pre-harvest interval(l) Remarks may include: Extent of use/economic importance/restrictions (e.g. feeding,
grazing)/minimal intervals between applications)
3.1.4.1 Explanatory notes for presenting GAP information
General: all information should be presented in English. The information must comedirectly from approved labels.Specific notes:
Crop and/or situationThe crop should be described exactly as on the approved label. If the approved label isfor use on crop groups (e.g. “citrus” or “orchard trees”) this should be the entry in theGAP table. The individual crops included in the national grouping should be identified bytheir English names (local varieties in brackets) under “Notes” of the table, preferablyusing the commodity description given in the Codex Classification of Foods and AnimalFeeds.
CountryThe names of the countries whose GAP data are presented are recorded in English.
Type of pest controlledThe information can be given in the form of the English name of a specific pest or in theform of a "broader" group of related pest species, e.g. powdery mildews, spider mites,lepidopterous yeasts, etc. The use of a Latin name (between brackets) may often provideclarification. The use of very broad classes of pest organisms, such as fungus diseases,insect pests or similar indications, in general provides insufficient information andshould be avoided.
Formulation and type of treatmentThe formulation of the pesticide product should be presented with the two-letter codingsystem developed by GIFAP and adopted by FAO and CIPAC. The codes are given inAppendix III. The definition of the terms can be found in the FAO Manual on theDevelopment and Use of FAO Specifications for Plant Protection Products (4th edition).
The concentration of active ingredient in the formulated product has to bepresented for liquid formulations in g/l, such as EC (emulsifiable concentrate) or SC(suspension concentrate, also called flowable concentrate) provided that the label
instructions give the dosage rate in litres of the formulated product per ha or per 100litres spray liquid (or in similar measures). The concentration of active ingredient insolid formulations is expressed on a w/w basis as g/kg or % of active ingredient in thesolid product.
Application method, timing and numberThe type of treatment must be given in sufficient detail, e.g. the type of apparatus usedand its output, such as ULV, high volume sprayer, etc. There is often a link between thetype of treatment and specific formulations developed for such applications. It has to berecognised that the residue deposit from different types of treatment may differconsiderably, e.g. a ULV application may give rise to a larger residue deposit than a highvolume application, both with the same amount of active ingredient per hectare.
The residue at harvest consists for the greater part of the residue deposit, appliedat the last application. Since the persistence of the pesticide residue may be different indifferent times of the season, the growing stage at the last application should berecorded. For example, in moderate climate zones the residue decrease of severalpesticides in autumn is in general less than in high summer, due to the higher lightintensity (UV) and the higher temperature in the latter period. Code numbers used todescribe growth stages should be fully explained.
The number of treatments per season, including the normal interval betweenapplications in days. Indicate if the maximum number of treatments per season is acalculated value if this is not specified on the label. Since the treatment intervals, andthus the number of treatments, are often linked to dosage rates, the recommendedalternative situations should be clearly indicated, e.g. for scab control on apples dosageA is applied for preventive treatments at 7-8 days interval or a higher dosage B (= about1.5 x A) with an interval of 10-14 days. The interval between successive applications mayhave a considerable impact on the amount of residue deposit at a certain time sinceresidues from earlier applications of the pesticides may still be present at the time of asuccessive treatment.
Application rateThis should always be presented in metric units. Preferably the dosage rates in amountsof active ingredient are expressed in g or kg/ha. When indicated on the label, themaximum amount of active ingredient which can be applied within a growing seasonshould also be indicated. In cases where the indications on the label are given in g/hl orkg/hl (the spray concentration), this spray concentration should be presented and the kgai/ha equivalent should not be calculated with the average amount of spray liquid used perhectare. If prior compilations included calculated ai/ha values, this fact should be clearlydistinguished from labels instructions.
Pre-harvest interval (PHI), in days:The pre-harvest interval prescribed or recommended and stated on the label should bepresented for the commodities concerned. If different PHIs are recommended for thesame or similar commodity, e.g. for glasshouse or outdoor grown crops, or in the caseof higher dosage rates, the particular circumstances should be clearly indicated.Sometimes the timing is indicated in terms of crop growth stage, e.g. when the pesticideis recommended for use at a very early stage of the crop development, such as bud burstin apple and pears, pre- and post-emergence applications for weed control, etc. In suchcases the reference to the growth stage of last application can be extremely helpful to
clarify GAP . PHIs included in the GAP table should only be taken from explicit PHIstatements on approved labels.
In the case of direct treatment of animals, the withdrawal period or grazingrestrictions after application of pesticide should also be indicated.
3.1.5 Residues resulting from supervised trials
Supervised trials serve as the primary source of information for estimating maximumresidue levels and calculating International Estimated Daily Intake. This importantconcept has never been defined in FAO publications before this Manual (see definition,App. II).
The term “supervised trials” covers the application of a pesticide approximatingtargeted or authorised use methods, care in the whole procedure and reliableexperimental design and sampling. Residue trials performed along the lines described inthe FAO Guidelines on Producing Residues Data from Supervised Trials are considered bythe JMPR as supervised trials. New supervised trials should be planned, implemented,documented and reported according to the OECD (or comparable) GLP principles(OECD, 1992; 1993) or in compliance with national regulations which ensure thequality of residue data.
Maximum Residue Limits are largely derived from residue data obtained fromsupervised trials designed to determine the nature and level of residues resulting fromthe registered or approved use of the pesticide. Since this work will usually have beendone before registration is obtained, in many cases the trials should be based on theintended registered use. Since the compounds are evaluated by the JMPR after they havebeen registered by national authorities (see criteria for selecting pesticides forevaluation in Chapter 2), some of the trial data may not be relevant for JMPRevaluations. Therefore only supervised trial data reflecting the current GAPs should besubmitted. Residue data should be presented primarily for mature crops at normalharvest. However, where a significant part of the consumable crop is present at the timeof application, some residue dissipation studies are required to complement the residuedata obtained at normal harvest.
At present there is no internationally agreed minimum data base required forestimating maximum residue levels. The subject is being discussed and elaborated underthe auspices of the OECD Pesticide Forum.
For estimating maximum residue levels of pesticide residues in commoditiesmoving in international trade, results of supervised trials representing the typicalagriculture practices, growing and climatic conditions prevailing in all exportingcountries should ideally be considered. Therefore, it is in the interests of nationalgovernments and the responsibility of manufacturer to provide all relevant validsupervised trial data and supplementary information to the FAO Panel in order to ensurethat the recommended limits cover the maximum residues arising from the authoriseduse of a pesticide and a realistic estimate can be made for the long- term intake ofresidues.
It is emphasised, however, that the JMPR performs the evaluation of thesubmitted information and estimates maximum residue levels if the database consideredsufficient, regardless of whether it represents world wide use or is limited to a region.
The number of trials (generally minimum 6-10) and samples is dependent on thevariability of use conditions, the consequent scatter of the residue data, and theimportance of the commodity in terms of production, trade and dietary consumption.Several residue data should be available from trials, preferably carried out in at least twoseparate years or at least representative of different weather conditions in accordance,or approximately in accordance ,with Good Agricultural Practice. If uses are authorisedin regions with substantially different climatic conditions, trials should also be carriedout in each region.
To ensure the availability of all detailed information necessary for evaluation,copies of the complete original reports on the supervised trials have to be submitted,preferably in English or with sufficient keys or translation to facilitate review.. Inaddition, the results of supervised trials should be summarised in the form given in Table3.1.5.1. The explanations for the entries in the table are the same as those given under“Use pattern” in the previous section. The location of trials should be given by countryand region within that country. Names of countries should preferably be recorded inEnglish. An acceptable, but less preferred, alternative is to use the ISO alpha 3 codemade up of 3 capital letters (ISO, 1993).
Based on the experience of the FAO Panel, the presentation of the followinginformation in the summary of supervised trials is often insufficient or ambiguous, andneeds special attention. The supplementary information and/or explanation of trialconditions can be given as remarks or footnotes.
Description of crop, Other names (varieties or cultivars) can be given in brackets.
Dates of application in relation to growth stage and intervals between applications andbetween last application and sampling. Clear indication of the related dates ofmultiple applications and sequential sampling is of special importance.Especially important is information on the intervals of handling and storageconditions from sampling to sample storage, and intervals and conditions ofsample storage prior to analysis.
Method of application in relation to GAP . Application rate in metric units.
Sampling method should be described in detail, including the number of primary samplesin the composite sample and the total weight of composite sample, and themethod of preparation of subsamples from a bulk sample. In the case of newtrials, the sample sizes given in the FAO Guidelines on Producing Residues Datafrom Supervised Trials should be followed as far as possible (Appendix V).
Samples taken from replicate plots (in close vicinity and treated on the same daywith the same equipment using the same formulation at the same nominal rate)and replicate samples taken from a single plot should be clearly distinguished.
Sample preparation should be carried out according to the Codex Guide on “Portion ofCommodities to which Codex MRLs Apply” (Appendix VI). The portion of thecommodity which is analysed should be unambiguously described.
Table 3.1.5.1 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (Application on agricultural and horticultural crops )
Active ingredient : Crop/crop group :
Responsible body for reporting (name, address) : Submission date :
Country : Page :
Content of ai (g/kg or g/l) : Indoor/outdoor :
Formulation (e.g. WP) : Other ai in formulation :
Commercial product (name) : (Common name and content) :
Producer of commercial product : Residues calculated as :
1 2 3 4 5 6 7 8 9 10
Report-No.:
Location
incl.
Postal code
Crop
Variety
Date of (b)
(1) Sowing or
planting
(2) Flowering
Application rate per treatmentDates of
treatment(s) or
no. of treatm.
and
Growth
stage at last
treatm. or
date
Commodity,
Portion
analysed
(a)
Residues
(mg/kg)
PHI
(days)
(d)
Remarks: 9 (e)
(3) Harvest kg ai/ha water l/ha kg ai/hl last date
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Explanatory notes for Table 3.1.5.1:
(a) According to Codex Classification/Guide
(b) Only if relevant
(c) Year must be indicated
(d) Days after last application (Label pre-harvest interval, PHI, underline)
(e) Remarks may include: Climatic conditions; Reference to analytical method and information on which metabolites are included
Note: All entries to be filled in as appropriate
When the residues in edible and inedible portions are analysed separately the massratios of the two portions should be reported for each sample. (Very often thisinformation is missing. It should be noted that, for instance, residue data measuredin citrus pulp alone are useful for estimating dietary intake but cannot be used forestimating a maximum residue level.)
It is important for the JMPR to be able to clearly identify the portion ofcommodity in which the residues were determined. For instance, in the case of:
• cereal grains some grains and seeds are still in the husks, and for rice resultsare often reported on polished rice. (The residue levels are usuallyconsiderably different for those sorts of commodities. Furthermore, the ricecommodities analysed should be in the form in which they may enterinternational trade.)
• stone fruit, the data should clearly indicate whether it is expressed on the wholecommodity without stem or with stone and stem removed.
• animal products, for fat soluble pesticides, the data for meat should indicatewhether it is expressed on the whole trimmable fat basis or on extracted orrendered fat and the types of fat involved. If expressed on rendered or extractedfat, the percentage of fat and moisture content in the trimmable fat should beincluded.
Analysis of samples should be carried out including all residues significant for bothresidue definitions (MRL compliance and dietary intake assessment). Theconcentration of residue components should be determined individually as faras technically possible. The concentrations of individual residues should bereported separately. The total residue may be calculated additionally. In thelatter case the conversion factors used for the calculation should also bereported.
The recovery values obtained at different concentration levels should be reported,but the residues measured should not be corrected for recovery. If the correctionwas done by the laboratory, this fact should be specifically mentioned togetherwith the reasons for the correction and the method used for correction.
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The analytical replicates (obtained by analysing replicate portions of the samelaboratory sample) should be distinguished from results of replicate samples. Theaverage value of the analytical replicates should be included in the summary table(Table 3.1.5.1).
When primary samples are analysed, the weight of the primary samples should beincluded in the report.
The method of expression of residues should be clearly indicated including, forinstance, conversion factors applied, correction for blank or control samples, orrecoveries.
The residues in animal feed should be reported on dry weight basis (Chapter 5.5,Expression of Maximum Residue Limits). If it is not expressed on the dry weightbasis this should be clearly stated, together with any information on the moisturecontent.
Data from alternative experimentsIt is not possible to carry out supervised trials on all varieties and cultivars ofcrops, nor even on all crop species on which a pesticide may be used. Theresulting lack of residue data from supervised trials led the 1978 JMPR toconclude that certain comprehensive selective surveys, which included many ofthe essential features of supervised trials, could be of great value in proposingMRLs, and submission of such data for consideration was encouraged. Withregard to such selected surveys ,information must be available on the usepractices leading to the residues in the survey. The 1980 JMPR, in introducing theexpression "supervised uses", accepted these residue data as one of the sourcesfor the estimation of maximum residue levels. Such data should be viewed assupplementary to supervised trials data and would assist in extrapolations to minorcrops.
The JMPR is frequently confronted with difficulties of not having data availableeven for important food commodities and especially for commodities grownextensively in tropical regions and developing countries. It has been recognisedthat the food industry, including plantations and processors, often has informationthat would be valuable for the estimation of maximum residue levels and everyeffort should be made and support should be given to enable the data to be madeavailable.
The JMPR considers more broadly based monitoring studies on samples ofunknown history to be of little value in setting MRLs. They may be used, however,for the estimation of Extraneous Residue Levels (ERLs, see section 5.4.3).
3.1.5.1 Information and data from livestock transfer (feeding) and external animaltreatment studies
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Animal transfer studies use unlabelled compounds to establish the relationship betweenlevels in feed and likely residues in tissues, milk and eggs.
Livestock transfer studies with poultry, lactating cows (goats) and pigs aregenerally required where significant residues (>0.1 mg/kg) occur in crops orcommodities fed to animals and metabolism studies indicate that significant residues(>0.01 mg/kg) may occur in edible tissues and/or that the potential for bioaccumulationexists. Feeding studies are usually carried out using the parent compound, which isnormally the residue of greatest significance on the treated crop. In cases where this isnot so, the animal transfer studies should be carried out using a metabolite or a realisticcrop residue mixture. In some cases the use of field aged residues is preferable.
When only low levels (<0.1 mg/kg) of residues are found in feed items theanticipated animal dietary burden and the results of the metabolism studies must beconsidered. The latter may indicate that residues in animal commodities would be wellbelow detection limits and thus further animal transfer studies are not necessary.
Where external treatment of animals is needed, this is best carried out with theformulated product in a manner which reflects the proposed use. When a pesticide maybe applied in more than one type of formulation or by more than one mode of treatment,separate studies reflecting the usage or combination of usages are required. If thelivestock is exposed to the pesticide both in feed and as a direct treatment, the residuestudy should reflect the level of residues to be expected from the combined exposurescenarios.
When the use of a pesticide in agricultural buildings is such that restrictionscannot preclude the possibility of residues in meat, milk, poultry or eggs, residue studiesshould be carried out reflecting the maximum conditions of exposure. Separate studiesare required for ruminants (cattle), non-ruminants (swine) and poultry (chicken). Thestudies should reflect all possible residue transfer routes such as: direct absorption,direct consumption or direct contamination of milk from milking equipment.
General guidance with respect to the role of livestock metabolism and feedingstudies in the estimation of Maximum Residue Limits by the JMPR may be found in theFAO Guidelines on Producing Residues Data from Supervised Trials. This guidance or itsfuture updates should be followed in performing animal transfer studies.
According to the above-mentioned FAO Guidelines the feeding study should include a control group,group fed at the level of expected intake and a group dosed with an exaggerated level (3-5x, occasionallya higher level, 10x, may be needed). The latter will allow an estimate of what will happen if the normallevel is exceeded, will indicate whether residues are proportionate to the intake and will provideadditional data if new uses of the product are introduced.For these studies, the number of animals in each treated group should be at least 3 for larger animals(cows and goats) and 5-10 for poultry (laying hens). Cows should be in mid-lactation producing anaverage milk yield, and chickens should be in full egg production before dosing is started.
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It is also important that the study period is long enough to reach plateau levels forresidues in meat, milk and eggs and to observe the rates of decline of the residue levelswhen the intake of feed with pesticides has ceased.
The documentation of animal feeding studies should include information on:• number of animals per feeding group,• weight of each animal,• nature of the residue or compound being dosed (pure compound, aged residue,
mixture of parent and metabolite, etc.),• dose rates per day (mg compound/kg bw/day or mg compound/animal/day),• feeding levels (ppm in the feed on a dry weight basis),• feed intake (dry weight basis),• description of the feed,• milk or egg production,• duration of dosing and withdrawal, times for milk or egg collection and animal
slaughter, and• residue levels in tissues and milk or eggs.
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Note:
For fat-soluble pesticides in both feeding and direct animal treatment trials, thefat samples analysed should be fully described because residue levels may varyin fat from several fat depots within the body of the same animal. The fatdescription should include:
w the nature of the fat (e.g., peri-renal, subcutaneous);
w location in the animal body (if more than one possibility); and
w lipid content (rendered or extracted fat may be assumed as 100% lipid).
Residue levels of fat-soluble pesticides may also depend on the conditionof the animal, which should also be recorded.
3.1.5.2 Information on veterinary uses
When a compound is used both as a pesticide on crops and for direct animal treatments(veterinary uses), full information on approved uses for both purposes and data fromresidue trials according to the approved uses, together with metabolism data in animals,should be included in the submission to the FAO Panel.
In the case of the first evaluation of a compound or re-evaluation within theperiodic review, veterinary uses will be treated in the same way as all other uses. Ifinformation is not supplied, the FAO Panel will not recommend MRLs coveringveterinary uses for new compounds and will recommend withdrawal of the old MRLswhich were based on veterinary uses.
3.1.6 Fate of residues in storage and processing
Once the residue has been identified, information on its fate during storage andprocessing should be included where available.
3.1.6.1 Information and data from trials on stored products
When residue data are submitted to the JMPR from treatment on stored products asgrains and seeds the treatments are often carried out in a number of stores with variableconditions with regard to temperature, humidity, aeration, etc. Information should beavailable on the use practice and all the conditions under which the products are kept.
Treatments of grain and other products in store give rise to particular difficulties.Pesticides used for storage vary considerably in stability. In addition to the ambienttemperatures, varying from tropical to temperate, moisture content and aeration caninfluence the rate of disappearance. Application of pesticides can vary fromcommodities stacked in sacks to automated systems in large-scale silos. In addition, thevariability of residues within a store (i.e. intra-store variability) can be particularly high,
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for instance in situations such as fogged potatoes in box stores. For this reason samplingprocedures must be designed to obtain a sample representative of the lot.
3.1.6.2 Information and data on residues in processed food
The need for data on residues of pesticide in processed food has increased considerablyduring the past few years. The estimation of International Estimated Daily Intake (IEDI)also requires information on residue levels in processed commodities and in the edibleportion of raw agricultural commodities.
Processing studies are required to determine whether residues in raw agriculturalcommodities (RAC) may be expected to degrade or concentrate during food processing.In certain cases the effect of household cooking operations should also be studied. RACsamples used in processing studies should be field-treated at maximum recommendedand/or exaggerated rates to contain sufficient residue levels for the determination ofprocessing factors for the various by-products. Processing studies with spiked samplesare not acceptable unless it can be demonstrated that the residue in RAC is entirely asurface residue.
processing factor = residue level [mg/kg] in processed product/residue level [mg/kg] inRAC
The processing factor should be explicitly defined in terms of residue levels. Inmany cooking operations changes in moisture level cause changes in residue levelswhich are unrelated to changes in the total amount of residue.
Depending on the type of pesticide and its intended use these data could includestudies on the chemical composition and level of residue after:
• storage at normal storage temperatures for typical storage periods • processing.
The following processing methods have been identified as being widely used byindustry and/or by consumers:
• Drying (e.g. dates, figs, grapes) • Canning (e.g. fruits, vegetables, pineapples) • Juicing (e.g. citrus juice, tomato juice) • Milling (e.g. wheat bran, flour, whole meal flour) • Baking of bread • Brewing (e.g. hops), wine making (e.g. grapes) • Oil extraction and refining (e.g. olive oil, rapeseed oil) • Refining (e.g. sugar) • Cooking, including boiling, cooking in water (e.g. potatoes, rice,
vegetables), frying (e.g. potato, meat) and microwave cooking.
Processing studies should simulate commercial practices as closely as possible.
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Usually one or a few processing studies are sufficient for each commodity.However, where the processed product is an important part of the diet at least threestudies are normally preferred. It is advisable, in any case, to take and analyse more thanone sample from the RAC and the processed fractions.
3.1.6.3 Information and data on residues in the edible portions of food commodities
The section should include all the information on residues in the edible portion ofcommodities for estimating dietary intake. This information is especially important inthe case of crops for which maximum residue levels are estimated for the wholecommodity as marketed and whose outer parts, e.g. the peel of bananas, citrus fruits andmelons, are normally discarded before consumption or processing. This section shouldthus represent a summary and conclusions of the information on storage and processing,also taking into account the likely residues in the residue trials.
3.1.7 Residues in food in commerce and consumption
This section should summarise any available monitoring data (including total diet studies,market basket studies, etc.) relevant to the pesticide under review. This information is ofparticular interest for further refining of the dietary intake estimates.
Monitoring data are the basis for establishing ERLs for pesticides which havebecome environmental contaminants (Section 5.4.3).
3.1.8 National Maximum Residue Limits
National MRLs should be reported exactly as they are published. The English translationof the commodity description should be as accurate as possible and must not beconverted to the presumably equivalent Codex descriptions. The portion of thecommodity to which the MRL applies should be specified if it is different from thatrecommended by the Codex Guide. The national residue definition should be given.
3.2 Reconsideration of previous recommendations
In the light of new uses of a compound or additional information on its residues thecompounds may have to be re-evaluated, in which case all new information, additions orcorrections have to be presented.
The new information and data will be mainly related to additional GAP and newdata from supervised trials, which enable the JMPR to estimate maximum residue levelsand eventually propose MRLs for additional commodities, change of established MRLsor confirm existing MRLs. Other types of information may also be submitted, such asreports about additional metabolites which were unknown at the time when the pesticide
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was first evaluated; ratio and magnitude of the parent compound and/or the metabolites inadditional matrices; new reports about animal feeding studies, improved analyticalmethods with lower limits of determination and improved ability to differentiate betweenparent compound and/or between metabolites.
It is emphasised that recommendations of the FAO Panel can only be based oninformation available to the JMPR, and requests or suggestions from the CCPR forchanges of recommendations should always be accompanied by clear statement of thereason for the referral, and must be supported by the data necessary for the JMPR to(re)consider the issue.
The experience of the meeting shows that often the information available tonational governments has not been provided to the JMPR. The full documentationavailable to the governments should been provided to resolve questions referred to theJMPR.
3.3 Data requirements for ERL estimation
The Extraneous Residue Limit (ERL), for JMPR purposes, refers to a pesticideresidue arising from environmental sources (including former agricultural uses) otherthan the use of a pesticide directly or indirectly on the commodity (Appendix II). ERLsare estimated from residue data generated in food monitoring programmes.
In any proposal for ERLs there should be a clear statement that the pesticide (orany precursor) has no permitted uses on the crop, the animal or animal feeds. If formeruses have been discontinued, the date of the withdrawal should be provided.
Evaluation will require monitoring data and supporting information, which shouldinclude:
• Country
• Year or years
• Commodity description (Codex Classification of Foods and Animal Feeds) andportion analysed
• Pesticide, and residue definition
• Sample classification as import, export or domestic production andconsumption
• Statement whether the samples derive from random monitoring or are aimed ata particular problem or situation.
If the number of samples monitored is large, the information should besummarised in categories. For each pesticide/commodity/year, etc. combination, thesummary should show the following three categories:
• Number of samples analysed
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• Number of samples with residues below the limit of determination or the limit ofreporting
• Number of samples exceeding current MRL or proposed ERL and, in thiscategory, the individual residue values.
The detailed residue data should be presented in tabular form shown in Table 3.3.1. This format allows comparison with other data or combination with data from otherreports (Hamilton et al., 1997).
The results of monitoring programmes where no residues were detected shouldalso be reported to help develop a more complete picture of the extraneous residuesituation
Table 3.3.1 Standard format for reporting pesticide residues monitoring data
Country: ...................... Residue definition: ........................................Commodity:.................... Limit of reporting (LOQ, mg/kg):.......................................Codex or National MRL: ............................
Yea
r
No. of No. of No . of Number of samples in residue range (mg/kg) *
samples
analysed
residue
s
detecte
d
residue
s <
LOQ
≤0.005 >0.005
≤0.01
>0.0
1≤0.
02
>0.0
2≤0.
05
>0.0
5≤0.
1
>0.1
≤0.2
>0.2
≤0.5
>0.5
≤1
>1 ≤2 >2
≤5
>5
≤10
Note: * The residue ranges are to be selected according to the residue levels detected.
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4. PREPARATION OF DATA SUBMISSIONS FOR THE CONSIDERATION OF THEFAO PANEL OF JMPR
In most cases the submitted data are organised in a clear and logical format. In others,however, the data provided consist of a collection of reports and studies submittedwithout benefit of an index/table of contents or even a covering letter. These submissionsrequire a significant amount of work on the part of the FAO Secretariat and Panelmembers before the data are ready for evaluation.
The increasing workload of the FAO Panel and the detail required in the residueevaluations have led to the development of a procedure aimed at increasing the efficiencyof the operation of the FAO Panel through improving the consistency and quality of thedata submissions provided.
Manufacturers are requested first to submit a detailed index or directory ofinformation to be provided (by November of the year preceding the scheduled review).The working paper or monograph summarising the results of the trials and theconclusions drawn from them, together with copies of original reports, must besubmitted by 28 February of the year of the scheduled review.
The aim of the detailed index or directory is to ensure that an acceptable datapackage will be available for the consideration of the FAO Panel. The index or directoryprovides an opportunity for the data submitter to conduct a cursory overview of the datapackage and identify any outstanding gaps or to omit studies which are obviously not upto current standards. From this index, however, it is not possible for the FAO JMPR JointSecretary to determine the acceptability of residue data vis-à-vis the use pattern, theavailability of critical supporting studies, the monograph, etc.; initially that remains theresponsibility of the data submitter and ultimately the task of the FAO Panel.Furthermore, a review of the directory prior to submission of the actual data facilitatesplanning for the JMPR and helps ensure an equitable distribution of work among thePanel members. A comprehensive directory of the data provided makes it easier for thereviewer to find the relevant section or study, particularly in a large submission. Thesedirectories would provide a permanent record of the data submitted and facilitate accessto the information by the Panel member.
The preparation of a draft working paper or monograph is expected to facilitatethe evaluation of the data by the reviewer and the overall operation of the Panel. It is notintended as a substitute for the FAO Panel review of the individual study reports. Onlythose pesticides accompanied by a technical working paper or monograph which providesan evaluation of the information submitted would be accepted in the case of newcompounds and those for periodic review.
The detailed reports submitted to the FAO Panel in support of the working papermust be organised in such a way that they are readily accessible to the reviewer. It ispreferable to have the technical reports organised according to the standardised formatof the directory. The collation of the information according to the different sections and
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subheadings proposed here might still be accomplished with reports or submissionsdeveloped for national regulatory authorities.
A manual for FAO Panel members was published in the Report of the 1994 JMPRA revised version is attached to this document as Appendix X. The purpose of the manualis to assist members of the FAO Panel to prepare documents for the meeting in aconsistent format. It may also be useful to those preparing submissions for review.
4.1 Standardised format of the directory
In order to update the evaluation schedule for the FAO Panel, a detailed directory of theinformation to be submitted is requested as explained above. The information should bepresented (alphabetically according to author) under the following headings and sub-headings as proposed for the Residue Evaluations. It may also be useful to assign thesubheadings consecutive numbers within each section .
References in the directory should be in the format currently used in the ResidueEvaluations (see Appendix VII). Where possible the reference should include theVolume number of the submission where the study is located. In situations where thevolume number is not known at the time the directory is submitted, an amended directory(including the volume number) should be included with the final data submission.
The directory should, if at all possible, also be supplied in WordPerfect 5.1 orWord for Windows 6.0 format on 3.5" diskette. This would allow searching for aparticular commodity and provide the references in the correct format for incorporationinto the Evaluations.
The standard format for organising the data directory (index) of information to besubmitted for evaluation is given in Appendix VII.
4.2 Standardised format of the working paper/monograph
A submission to the FAO Panel should include a draft working paper, or monograph,which provides an evaluation of the available data. The primary objective is to give anoverview of the relevant residue data and critical supporting studies submitted to the FAOPanel for estimation of maximum residue levels. This working paper must be supportedby the original technical reports. The individual reports must be accurately referenced inthe submitted directory.
The working paper, or monograph, should provide an evaluation of the technicaldata. It should, where appropriate, relate the residue data to the residue definition,analytical methods, GAP information, dose levels in animal studies etc., and clearlydemonstrate the basis for a proposed MRL. The sub-sections describing supervised trialsshould follow the sequence of the Codex Commodity Classification and conclude withan evaluation of the information provided. In the case of submissions provided in supportof a new or existing MRL, the evaluation may be limited to a brief discussion of theavailable residue data and GAP information. In the latter case, new critical supporting
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studies are valuable information and should be submitted. The re-submission of oldstudies is not necessary.
Reports (in English) prepared by companies for submission to authorities in USA,Europe etc., are likely to be considered generally acceptable even though they are notnecessarily in the format specified here, provided a directory has been enclosed whichpermits the reviewer ready access to the individual technical reports. There may also bethe need for additions to such submissions, for example:i) commodity descriptions in Codex termsii) summaries of good agricultural practicesiii) summaries of residue data from supervised trials.
The data and information required for JMPR evaluation and the formatsrecommended for preparing the summary information are described in detail in Chapter3 (Data and Information Required for JMPR Evaluation). The information from theindividual studies should be organised according to the suggested subheadings in thedirectory with an evaluation of the available data in each subsection. Under the varioussubheadings, trial details relevant to the assessment of the data that might be consideredto influence the residues or the validity of the trials should be explained.
The work of the Panel would be facilitated if schematic diagrams of metabolismpathways were also included in electronic form.
Processing studies should be grouped according to the commodity or substrate ofinterest. It is often advantageous to summarise the data in tabular format. It is importantthat the information in such tables is set out carefully so that it is absolutely clear whichsample is derived from which product in the processing phase. The scale of theprocessing by the weight of commodity processed should be indicated. The review ofeach study should describe the field treatments and state the application rate in the study.
In view of the fact that some commercial processes are quite complex, a flowdiagram to explain the process would be useful.
The information on national MRLs is best summarised in tabular format. Thetypical column headings include country, commodity and MRL. Footnotes or an extracolumn will be necessary if countries use different residue definitions or the limits wereset on a portion of the commodity which is different from that recommended by theCAC.
4.3 Organization of the submission
The technical reports provided in support of the working paper or monograph should becompiled in separate sections as indicated below.
0. Directory1. Background Information2. Metabolism and Environmental Fate
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3. Methods of Residue Analysis4. Use Patterns5. Residues resulting from Supervised Trials6. Fate of Residues in Storage and Processing7. Residues in Food in Commerce or at Consumption8. National Residue Limits
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A table of contents should be included at the beginning of each volume. Eachvolume should be clearly labelled as per the example below:
Company nameDateCommon name of the active ingredientNumber of the volume and total number of volumes in the submissionTitle of the section
It would also be helpful if the cover of each volume could include a list ofcommodities dealt with in that volume (for residue trials, animal transfer, processing andstorage stability) and a list of animals, crops, soil and water (for metabolism).
Example: Bayer AGDecember 1992FenthionVolume 15 of 18
Section 5 Residues resulting from supervised trials
Citrus fruitslemons, oranges, tangelos
Pome fruitsapples, pears
At present a hard copy of the data is submitted directly to the reviewer, with acopy on optical disk or microfiche provided to the FAO Joint Secretary. The directoryshould indicate the form in which the copies of reports are provided. The preferredformat is the optical disc if the data are available in electronic files. In other cases themicrofiche of 15 cm x 10.5 cm sheets which accommodate 14 columns by 7 rows ofpages. Further reduction complicates the retrieval of the information.
It would greatly facilitate the work of the Panel members and FAO if the workingpapers, summaries of GAP and residue data could also be provided on diskette inWordPerfect 5.1. or Word for Windows 6.0 word processing format, and the diagramsof metabolism pathways were prepared applying a ChemWindow3 programme suitablefor inclusion of diagrams as a graphic in the document.
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5. THE JMPR PRACTICE IN ESTIMATING MAXIMUM RESIDUES LEVELS ANDPROPOSING MAXIMUM RESIDUE LIMITS
The Joint Meeting carries out a scientific evaluation and takes into account all availableinformation. Better evaluations result from an understanding of the processes of residuebehaviour rather than from only an empirical treatment of data. In addition, the availableinformation varies to a great extent. Therefore the JMPR does not follow rigid rules inits evaluations but considers the submitted information on a case-by-case basis. Thebasic principles outlined below are followed as far as practical and possible.
As part of the evaluation process the members of the FAO Panel prepare themonographs, including all relevant information concerning the pesticide, and theappraisal summarising the findings, conclusions and recommendations, and giving fullexplanation and reasoning for them. The monographs and appraisals are prepared in auniform format, described in the FAO Panel Manual attached as Appendix X, to facilitateaccess to the required information by the reader. The monographs and appraisals arepublished by FAO in the series Pesticide Residues in Food - Evaluations Part I. Residues. Inaddition, a short summary of information evaluated and the recommendations for eachcompound are included in the Report of the JMPR.
Some years ago the JMPR recognised the need to explain more fully the basis forits recommendations. During the past years, information on GAP and data on supervisedresidue trials are summarised in detail in the monograph and the reasoning behind theevaluation is explained. The increased volume of the evaluations is largely due to theinclusion of more detailed explanations.
5.1 Evaluation of available information
5.1.1 Chemical and physical properties of a pesticide
The purpose of evaluating data submitted to the JMPR on physical and chemicalproperties of pure active ingredient is mainly to recognise the influence those propertieshave on the behaviour of the pesticide during and after its application on crops oranimals.
The volatility of the compound and its stability in water and after radiation fromultraviolet light may considerably affect the disappearance after application.
The solubility of the pesticide is especially of great interest, as the ability of thecompound to penetrate plant and animal tissues is dependent on its solubility in water andorganic materials.
The physical property chosen by the JMPR to represent solubility in fat is theoctanol-water partition coefficient, usually reported as log POW.
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It should be noted that there are errors in estimates of log POW, with differences ofone unit for the same compound being reported. Different approaches to thedevelopment of these data often give different results. Interpretations must recognisethese differences.
The variable composition of some residues, e.g. where the residue is defined as amixture of parent and metabolites, presents a problem since the fat-solubilities of themetabolites may be different from those of the parent compound. In this case,information on the log Pow of each individual metabolite should be considered ifavailable. The relative concentrations within the mixture are also subject to change and,as a result, the tendency of the mixture to partition into fat will also change.
A further factor which may influence designation as a fat-soluble residue is thenature of the available residue data from supervised trials. Data are frequently reportedonly on a fat basis or only on a whole commodity basis.
The JMPR recommended that the octanol-water partition coefficient should be theprime indicator of fat-solubility, supplemented by inferences which may be drawn fromthe distribution of residues between muscle and fat tissues, when the residue consists ofa single compound. In cases where the residue is defined as a mixture of the parentcompound and metabolites, information on the log POW of the individual compoundsshould be considered if available.
The JMPR recognised that many compounds which are neither clearly fat-solublenor clearly water-soluble required special consideration.
In general, when log POW exceeds 4 the compound would be designated fat-solubleand when log POW is less than 3 it would not be so designated. Pesticides withintermediate log POW would be considered on a case-by-case basis.
5.1.2 Metabolism and degradation of pesticides after application on plants, animals and soil
One major route of disappearance of pesticides after application on plants,animals or soil is chemical degradation and metabolism at rates which are dependent onthe chemistry of the compounds and circumstances, such as temperature, humidity, light,surface of the crops, pH of crop liquid, composition of soils and other factors.Metabolism studies provide fundamental information on the fate of the compound and itsmetabolites, provide a qualitative semi-quantitative picture of the composition of theresidues and suggest probable residue behaviour. The results of metabolism studiessuggest target tissues in animals; other important guides to the site and level of residuesare whether the compound is absorbed by the leaves or roots of crops, whether it ismobile in the plant, and its persistence and mobility in soil.
Data on metabolism are used in evaluating both the toxicological and residueprofiles of pesticides. The FAO Panel examines the metabolism in experimental animalsand compares it with both that in food-producing farm animals and in plant species on
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which the pesticide is used. This is required to decide upon the relevance of thetoxicological studies to humans, and to define the residues in plants and farm animalproducts. The ADI estimate, based on toxicological studies in experimental mammaliananimals, is valid for foodstuffs only if the metabolite pattern is qualitatively and semi-quantitatively similar. If there are plant or farm animal metabolites (where there aresignificant residues in feed items) which have not been identified as mammalianmetabolites in experimental animals, the ADI does not encompass other metabolites andseparate studies dosing with these metabolites may be necessary for assessment of theirtoxicological properties.
The information on the composition of the terminal residue is used to assess thesuitability of the residue analytical methodology for the development of residue datafrom supervised trials and to decide on the definition of residues.
5.1.3 Information received on Good Agricultural Practices
An essential element to enable the JMPR to estimate maximum residue levels ofpesticides is information on Good Agricultural Practices. Normally the FAO Panel givespreference to GAP information provided by national authorities when submittedinformation is in conflict. The FAO Panel uses the information on national GAPs toidentify the likely scenarios which may lead to the highest residues in food or feed, andrelates these uses to the conditions prevailing in the execution of supervised trials.Therefore, information on national GAP from those countries in which the supervisedtrials have been carried out, or from countries in close proximity with similar climaticconditions and agricultural practice is of the utmost importance.
With regard to the required presentation of adequate information on GoodAgricultural Practice in the use of a pesticide in a country, the FAO Panel recognisedthat several countries may apply different pesticide use authorization systems. Some usea rigorous formal product-based registration scheme, while others use less formalauthorization approaches. The "authorised safe use" or “approved uses” from the lattercountries may still be included in the GAP Table provided that the country involvedsupplies the information on nationally approved uses or authorised safe use. The terms"approved" and “authorised” are understood as GAP information from countries which donot have a full registration scheme, but where there is a form of authorisation of use.This distinction recognises the different terminologies and approaches to GAPauthorisations at the national levels and does not imply that one national system ispreferred over another.
Registered and approved use of a pesticide may vary considerably from country tocountry and the use patterns are often very different, especially in regions with greatdifferences in climate. Growing conditions and, naturally, types of crops may also causedifferences in the use pattern. According to the definition of Good Agricultural Practice,a pesticide should be applied in such a way as to leave a residue which is the smallestamount practicable. Residue levels exceeding the smallest amount practicable, due tounnecessarily high application rates ("overdose") or unnecessarily short pre-harvestintervals (PHIs), are contrary to the concept of GAP.
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5.1.4 Residue data
5.1.4.1 Results of supervised trials
Estimation of maximum residue levels is mainly based on reliable residue data fromsupervised trials carried out in such a way that treatments in the trials are equivalent tothe uses according to Good Agricultural Practice. The importance of reliable data hasalready been emphasised in the requirements for information and data from trials.
The principles followed in evaluating supervised trial data are described in detailin section 5.4.
5.1.4.2 Results of selective surveys
Selective surveys may provide supplementary information which will assist inextrapolations (see also “Data from alternative experiments” in Section 3.1.5). As thenumber of supervised trials is always small in comparison with actual use situations, thesubmission and evaluation of alternative data are of importance.
5.1.5 Processing studies
"Processed food" in connection with establishing Maximum Residue Limits forpesticides means products resulting from the application of physical, chemical orbiological processes to a "primary food commodity" whereas primary food commoditiestreated with ionising radiation, washed or submitted to similar treatments are notconsidered to be processed food in this context.
Originally the main interest for processed foods was the types of processed foodswhich were important items in international trade, such as milled cereal grains and othergrain products, oil from oilseed, juice and dried fruit. There was a marked need forMRLs for those commodities, and a number of MRLs have been established over theyears. During the last five to ten years interest has increased considerably in obtainingbetter information about the residue level in other types of processed food, e.g. primaryfood commodities which are peeled, cooked or baked. Some of those commodities areusually not moving in international trade, but information on the residue levels isessential to obtain knowledge about the real intake of pesticides from food commoditiesfor which MRLs have been established. As in the case of edible/non-edible residuedistributions, this may have the consequence that higher MRLs are acceptable when it isdemonstrated that residues found in the whole commodity are dissipated or renderedharmless in food processing. Experience has shown that residue levels usually decreaseduring processing, such as peeling, cooking and juicing. In other cases the residue levelmay increase during processing as it often does in the case of oil from oilseeds andolives. However, in some cases the active ingredient can be transformed duringprocessing into metabolites that are more toxic than the parent compound.
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The JMPR is aware that there is a considerable trade in manufactured foods based, for example, on fruits, vegetables, cereals and meat. However, the variety of formsunder which the products are offered makes it impossible to recommend MRLs for allpossible processed foods. For this reason the JMPR has specified that, in the case ofprocessed foods for which no MRLs have been recommended, the maximum residuepermitted in the processed food should not be greater than the maximum residuepermitted in the equivalent weight of the raw agricultural commodity. The JMPRfrequently estimates maximum residue levels for important processed foods and feeds ininternational trade when residues concentrate in these products at levels higher than inthe raw agricultural commodities from which they are derived (e.g. oil, bran, peel, etc.).Even when the estimates are not recommended for use as maximum residue limits orwhen residues do not concentrate in the processed product, the JMPR will continue torecord in its monographs the effect of processing on the level and fate of residues infood. This has been found to be critical for better estimates of dietary intake ofpesticides.
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5.1.6 Results of national monitoring programmes
The results of national monitoring programmes are considered as supporting informationfor confirmation of practical applicability of estimated maximum residue levels. Theyare also useful for estimating dietary intake at national level. Data from nationalmonitoring programmes are essential for estimating ERLs.
5.2 Re-evaluation of compounds
5.2.1 Re-evaluation of additional information
Usually new information on GAP and related data from trials do not cause difficulties, ifthe data received are of the same type and in agreement with data from earlierevaluations. However, information about new developments in the area of metabolism ofthe compound may be more problematic. Such information may require that the originalresidue definition be changed, which means that evaluation of old and new data togethermay be very complicated. In a similar way, problems may arise when a residue definitionoriginally included two pesticides of which one of the compounds is also a metabolite ofthe other, and for toxicological or other reasons the decision is taken that the pesticidesmust subsequently be determined separately. In such a case old residue data are ofteninapplicable.
Improvements of analytical procedures may also cause difficulties. If the limit ofdetermination is lowered, the old residue data below the original limit of determinationare difficult to interpret and may be inapplicable and unavailable for later evaluations. Inthis context, as for the changes in the metabolism of the compounds, the whole set ofdata on the compound has to be taken into consideration and decisions have to be takenby the JMPR on a case-by-case basis.
In most of such cases, however, all of the information required for the scientificre-evaluation is not available to the JMPR. Therefore, such complex problems are bestand most efficiently handled during the periodic review of the compound for which allrelevant original reports are supposed to be re-submitted and can be taken intoconsideration.
5.2.2 Re-evaluation of compounds being in the CCPR periodic review programme
The periodic review programme requires different actions from those for the re-evaluation of additional information, called hereunder normal situation (i.e. other than inthe periodic review programme); consequently, those compounds to be evaluated withinthe periodic review programme must be clearly identified in advance.
As discussed in detail in Chapter 3, data submitters should supply all relevant validinformation at the time of the periodic review irrespective of whether it has beensupplied previously.
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The JMPR evaluates all relevant information on periodic review compounds interms of identity, metabolism and environmental fate (animal and plant metabolism,environmental fate in soil and in water/sediment systems), methods of residue analysis(analytical methods, stability of residues in stored analytical samples, residuedefinition), current use patterns (registered and officially authorised uses), supervisedresidue trials, fate of residues in storage and processing, residues in food in commerceor at consumption and national maximum residue limits, as in the case of a newcompound. However, the conclusions and recommendations are somewhat different inperiodic and normal reviews.
Comparison of the data evaluation of a periodic review compound with normal re-evaluation (re-evaluation of some particular information made available to the JMPR)clarifies the major differences.
New MRLs. If no MRL exists for the individual commodity or for the relevantcommodity group, there is little difference in the treatment of information suppliednormally or under the periodic review programme.
Existing MRLs. For an individual commodity in the normal situation, if new dataare supplied where an MRL already exists the data are evaluated and the MRL may or maynot require revision.
In the periodic review situation, where adequate information is supplied on anindividual commodity, the MRL is either revised or confirmed to be relevant to modernGAP.
In the normal situation, when information on a single commodity included in agroup commodity MRL is received evaluation would either show that the group MRLcould remain or that an individual MRL and a group (with specified exceptions) MRLcould be recommended.
In a periodic review when information on only a single commodity included in agroup commodity MRL is received it may be necessary to withdraw the group MRL andestimate a single-commodity MRL.
GAP information. Under normal circumstances if no new GAP information issupplied the MRL would remain. New GAP information may allow previously recordedresidue data to be reinterpreted to permit estimation of a new maximum residue level.
In the normal situation where new residue data are to be evaluated, judgement isrequired on a case-by-case basis to decide whether previously recorded GAP is stillvalid. GAP information recorded many years ago for some compounds may still beacceptable.
Under the periodic review programme the absence of GAP and residue informationbecomes significant. For example, if no GAP information is supplied for a particularcommodity the JMPR reviewer can assume that there is no GAP for that commodity.
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Only GAP supplied for the purposes of re-evaluation is considered valid. If no GAPinformation is supplied, withdrawal of the MRL will be recommended.
Supporting Studies. Critical supporting studies, which were previously referred toas residue supporting information (metabolism, animal transfer, processing, analyticalmethods and storage stability of analytical samples), are evaluated to assist with theinterpretation of data from supervised residue trials, influence the residue definition,validate residue and other trials and provide further information on residues in food asconsumed. The FAO Panel may not recommend MRLs for new or periodic reviewchemicals in the absence of critical supporting studies if their omission is not adequatelyjustified.5.3 Definition of residues
For the purposes of an MRL or STMR, a pesticide residue is defined as thecombination of the pesticide and/or its metabolites, derivatives and related compoundsto which the MRL or STMR apply.
Definitions of residues which have been applied in the past are sometimesarbitrary. For this reason, and because of the various purposes for which they are used,definitions of residues established by national governments often do not agree.
The basic requirements for the definition of residues are that it should: - be most suitable for monitoring compliance with GAP, and - include compounds of toxicological interest for dietary intake estimations and
risk assessment.
The two requirements are sometimes not compatible and, as a compromise,various definitions of residues are possible. For some compounds it may be necessaryto establish separate residue definitions for enforcement and dietary intake purposes.The residue definition for dietary intake purposes should include metabolites anddegradation products of toxicological concern irrespective of their source, whereas theresidue definition for compliance with MRLs needs to be a simple residue definition(i.e. indicator molecule) suitable for practical routine monitoring and enforcement ofthe MRL at a reasonable cost.
Although metabolites, degradation products and impurities are included in thedefinition of pesticide residues, this does not necessarily mean that metabolites ordegradation products should always be included in the residue definition forenforcement (MRLs) purposes or for estimation of dietary intake (STMR). Inclusion ofmetabolites in the residue definition depends on a number of factors, and the decisionon whether metabolites should be included is very complex and decisions have to bemade on a case-by-case basis.
The metabolites have generally been identified and quantified in metabolismexperiments with methods based on the use of labelled compounds. In other cases themethods used for supervised trials are complicated or require sophisticatedinstrumentation and, therefore, they are unsuitable for regulatory analytical work.
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Furthermore, some countries may experience extreme difficulty to procure metabolitesfor use as standards in the analytical work.Therefore, inclusion of, in particular, polar metabolites in the residue definition formonitoring compliance with GAP is not practical.
It should be stressed that in choosing the appropriate analytes and the analytical methodfor the testing of the residue trials samples, the manufacturer/sponsor must consider theneeds of both risk assessment and compliance. In practice this will mean generating thedata in such a way as to give the flexibility to establish two separate residue definitionswhere appropriate. In cases where it is likely that a multi-component residue definitionwill be required for risk assessment purposes, the manufacturer/sponsor should, intesting field trial samples, either:
(i) analyse separately for the individual components of the residue, whereanalytical methodology allows, rather than carrying out a total residue analysis
or
(ii) if total residue methodology is used to produce data for risk assessment, andthe suitable “indicator molecule” can be analysed with a multi-reside procedure, asecond series of analyses of the field trial samples should be carried out for theindicator molecule (e.g. parent compound).
This approach allows the risk assessment to be carried out on the toxicologicallysignificant residue components whilst ensuring that data are available to allow a differentsimple residue definition to be established, where appropriate, for compliance with theMRLs.
In cases where the manufacturer/sponsor has submitted residue trials data in which totalanalytical methodology has been used and it is not possible to identify a suitable simpleresidue definition for practical routine monitoring and enforcement of the MRL atreasonable cost, the FAO Panel may be unable to estimate MRLs for the compound.
The following examples further illustrate the complexity of the situation.
Several pesticides are metabolised to a compound, which itself is used as apesticide (example: benomyl → carbendazim), and in addition, in some such cases, thetoxicology is substantially different for the pesticide and the metabolite (example:dimethoate → omethoate).Whenever possible, the parent pesticide and its metabolite(s) used as pesticides shouldbe subject to separate MRLs. Analysing food commodities in trade for the metabolitemay provide no information on which compound was used.
Where it is not possible to set separate MRLs because the parent pesticide isdegraded rapidly or analytical method is not available for measuring and distinguishingthe parent compounds (examples: ethylene-bis-dithiocarbamates, benomyl →
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carbendazim, thiophanate-methyl → carbendazim), the MRLs applying to the pesticidesconcerned can only be determined in terms of the metabolite(s) or conversion products.
Another problem occurs when the metabolite from a pesticide may also originatefrom sources other than use of the pesticide. In this case, a residue of the metabolitepresent in a sample is of no use as proof of illegal use of the pesticide, and themetabolite should not be included in the residue definition for MRL (example;cyromazine → melamine, also prometryne→ melamine).
The JMPR considers the following factors when proposing a residue definition:
• The composition of the residues found in animal and plant metabolismstudies.
• The toxicological properties of metabolites and degradation products (forrisk assessment).
• The nature of the residues determined in supervised residue trials.• The fat-solubility.• The practicality of regulatory analytical methods.• Whether metabolites or analytes common to other pesticides are formed.• Whether a metabolite of one pesticide is registered for use as another
pesticide• The definitions of residues already established by national governments and
long-established and customarily accepted definitions.
5.3.1 Principles followed in defining residues for MRLs
The definition of residues for enforcement purposes should be as practical as possibleand preferably based on a single residue component - the parent compound, a metaboliteor a derivative produced in an analytical procedure - as an indicator of the totalsignificant residue. The selected residue component should reflect the applicationcondition (dosage rate, pre-harvest interval) of the pesticide, and it should bedetermined with a multi-residue procedure whenever possible. Monitoring foradditional residue components only adds to the cost of analyses.
The advantage of this approach is appreciable as overall costs can be reduced andmany more samples may be analysed by the regulatory laboratories. In addition, morelaboratories can participate in regulatory monitoring of residues, since a relativelysimple and rapid analytical procedure may not require the expensive equipment and timenecessary for an extensive determination of all components of a residue. Nevertheless,the expression of residues with a single compound does not reduce the data requirementas full information on the composition of total residue, and on the relative ratio ofresidue components, is needed before it can be determined whether a single compoundcan be used. Furthermore, such full information is often needed for risk assessmentpurposes.
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As far as possible the same definition of the residue should apply to allcommodities, although there are exceptions. For example, if the major residue in animalcommodities is a specific animal metabolite a definition which includes that metaboliteis needed for regulatory monitoring. However, the animal metabolite is not required inthe residue definition for crop commodities if it is not found in the crops. Separatedefinitions would then be proposed for commodities of plant and animal origin.
Example: residue definition of thiabendazole: thiabendazole or, in the case of animalproducts, the sum of thiabendazole and 5-hydroxythiabendazole.
It is generally preferable to express a residue in terms of the parent compound.Even if the residue consists mainly of a metabolite, the residue should be expressed interms of the parent pesticide after molecular weight adjustment. Some examples aregiven to illustrate the practical application of the principle:
If the parent compound can exist as an acid or its salts, the residue is preferablyexpressed as the free acid.Example: 2,4-D.
If metabolites are known to be present in significant amounts, but the analyticalmethod measures, the total residue as a single compound the residue is expressed as theparent compound. The metabolites included in the residue should be listed.Example: the residue definition of fenthion includes fenthion, its oxygen analogue and
their sulphoxides and sulphones which are measured after oxidation as fenthionsulphone; the reside is expressed as fenthion.
There have been exceptions:Example: the current residue definition of amitraz is: the sum of amitraz and N-(2,4-
dimethylphenyl)-N’-methylformamidine expressed as N-(2,4-dimethylphenyl)-N’-methylformamidine.
Ideally it should be possible to measure the residue as defined, with a limit ofdetermination (LOD) adequate for proposed MRLs, with a high degree of specificity bya multi-residue regulatory analytical method. Although circumstances may warrantexceptions, the definition of a residue should not normally depend on a particularmethod of analysis, which means that the definition should not contain the words"determined as". However, the only way to produce a practical definition for residues ofthe dithiocarbamates is to describe the residue as ".... determined and expressed as ....".Example: residue definition of thiram for compliance with MRLs: total
dithiocarbamates, determined as CS2 evolved during acid digestion andexpressed as mg CS2/kg sample.
Where the residue is defined as the sum of the parent compound and metabolitesexpressed as the parent, the concentrations of the metabolites should be adjustedaccording to their molecular weight before being added to produce the total residue. Thewords "expressed as" in the residue definition signify adjustment for molecular weight.
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Example: residue definition of methiocarb: sum of methiocarb, its sulphoxide and itssulphone, expressed as methiocarb.
No allowance was made for molecular weights in the definitions of residues ofsome older compounds. Because such definitions are widely accepted the need forchange should be carefully considered. The best time for the reconsideration of anexisting residue definition is during a periodic review.Examples: (no recalculation for molecular weight)
residue definition of DDT: sum of p,p’-DDT, p,p’-DDE and p,p’ TDEresidue definition of heptachlor: sum of heptachlor and heptachlor epoxide
Metabolites arising from different sources should generally be excluded fromdefinitions of residues for enforcement purposes unless the definition is a combinedone covering the various sources. For example, p-nitrophenol arises from both parathionand parathion methyl. It is often a major component of aged residues but is not includedin the definitions of the residues.
Where a metabolite of one pesticide is registered for use as a second pesticide,separate MRLs would normally be established if the analytes of the two compoundswere different. Preferably no compound, metabolite or analyte should appear in morethan one residue definition.Example: Triadimenol is a registered pesticide and a metabolite of triadimefon. The
MRLs for triadimefon are for triadimefon only. The MRLs for triadimenol arefor triadimenol only, but cover triadimenol residues arising from the use ofeither triadimefon or triadimenol.(Before 1992 the definition of the triadimefon residue included triadimenol,and an analyst detecting triadimenol in a sample could not be certain whetherto compare the residue with an MRL for triadimefon or triadimenol.)
There are cases of pesticides, however, where the chemical instability of theparent compound and/or the limitation of analytical methodology do not allow theapplication of the above principle. In such cases the residue definition has to be basedon the stable common moiety.Examples: residue definition of benomyl,: thiophanate-methyl and carbendazim
Note: According to the current practice of JMPR, the residue definitionwould be1: the MRLs cover carbendazim residues resulting from direct use, oroccurring as a metabolic product of thiophonate-methyl and benomyl andintact (i.e. unmetabolised) thiophonate-methyl and benomyl expressed ascarbendazim.”
A major part of the residue of some pesticides is bound or conjugated, with thefree residue disappearing very quickly. The bound or conjugated residue is then a better
1 Presently the following explanation is given in the Codex table of recommendation: MRLs cover carbendazimresidues occurring as a metabolic product of benomyl or thiophanate-methyl, or from the direct use ofcarbendazim. Source of data (the MRL is based on the use of the specified pesticide): B, benomyl; C, carbendazim;Th, thiophanate-methyl. Note that this definition does not incorporate explicitly the parent residues of benomyland thiophanate-methyl being present in/on the commodity.
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indicator for monitoring compliance with GAP . If the residue is defined as bound orconjugated there must be a clear instruction for the regulatory analyst as to how tomeasure it. The instruction could be to extract samples with a particular solvent underspecified conditions, or perhaps to begin with a hydrolysis step, etc.Example: residue definition of bendiocarb:
commodities of plant origin: unconjugated bendiocarb;commodities of animal origin: sum of conjugated and unconjugatedbendiocarb, 2,2 dimethyl-1,3-benzodioxol-4-ol and N-hydroxymethyl-bendiocarb, expressed as bendiocarb.
Fat-solubility is a property of the residue; it is primarily assessed from theoctanol-water partition coefficient and the partition of the residue between muscle andfat observed in metabolism and animal transfer studies. Section 5.1.1 providesguidelines for deciding whether a pesticide is fat-soluble. Sampling protocols foranimal commodities depend on whether a residue is fat-soluble or not.
The JMPR has for many years included the qualification ‘fat-soluble’ in thedefinition of the residues of fat-soluble pesticides, using the expression:
“Definition of the residue: [pesticide] (fat-soluble)”
As different definitions of residues may be needed for estimating dietary intakeand for assessing compliance with MRLs, however, the 1996 JMPR recommended that‘fat-soluble’ should no longer be included in the definition of the residue. In order toavoid confusion while conveying the information that a residue is fat-soluble, the JMPRagreed that the definition of a residue should include only the chemical species ofconcern and a separate sentence should indicate that the residue is fat-soluble.Examples:(a) Definition of the residue for compliance with MRLs and for estimation of dietary
intake: diazinon(The residue is fat-soluble.)
(b) Definition of the residue for compliance with MRLs and for estimation ofdietary intake:
sum of aldicarb, its sulfoxide and its sulfone, expressed as aldicarb
Separate definitions of residues for enforcement (the estimation of maximumresidue levels and compliance with MRLs) and for dietary intake purposes should beestablished when the requirements are in conflict.Example: definition of the residue of thiram for compliance with MRLs: total
dithiocarbamates, determined as CS2 evolved during acid digestion andexpressed as mg CS2/kg
Definition of the residue for estimation of dietary intake: thiram
As the above examples indicate, the definition of residues has not always beenconsistent. Therefore all residue definitions are re-examined during the periodic reviewof the compounds.
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From 1995 the FAO Panel includes in the Monographs a special section onresidue definition with appropriate explanation. It will now be easier for the reader tofind an explanation for the definition of the residue. It is located in the monographs underthe section on Methods of Residue Analysis.
5.4 Estimation of maximum residue levels
The JMPR examines the possibility of estimating maximum residue levels based on thesubmitted information and data, and subsequently proposes Maximum Residue Limits incommodities for pesticides used according to Good Agricultural Practice.
Maximum residue levels are estimated for residues in or on the portion of thecommodity to which Codex MRLs apply. For dietary intake purposes the residue levelsare estimated on the edible portion of the commodity (see Chapter 6).
In addition to primary and some processed food commodities, when the availableinformation permits, JMPR also recommends MRLs for animal feeds and foodprocessing by-products which can be used as animal feed. The latter are commodities oftrade and therefore require Codex MRLs if pesticide uses result in detectable residues inthe feeds. Residues in feeds may also lead to detectable residues in animal tissues, milkand eggs, necessitating MRLs for these commodities. In addition, some by-products offood commodities (e.g. apple pomace, grape pomace) and food commodities themselves(e.g. cereal grains) may be used as feedstuffs for food-producing animals.
In estimating maximum residue levels, the FAO Panel takes into account allrelevant information especially the residues arising from supervised trials and therelation of trial conditions to the established GAP . The procedure for estimating andrecommending MRLs for Codex purposes may be somewhat different from thatapplicable at national level. The Codex MRLs should cover residues deriving fromauthorised uses world-wide, which reflect greatly differing agricultural practices andenvironmental conditions.
An awareness of the expected variability of residues is necessary. If the data trulyreflect the range of conditions, application methods, seasons and cultural practices likelyto be encountered commercially, then considerable variation in the resulting residuelevels is expected. Where copious data are available, consideration of the spread andvariability of the residues helps to avoid misleading interpretations of small differencesin estimates of the maximum level. Where only limited data are available, theinterpretation of fine differences is not valid. It is not a criticism to say that the data arewidely spread and variable. If results have been obtained at a number of places over someyears they are likely to be a better approximation to commercial practice and will bewidely spread. In addition to the variability of residues within a confined area which canbe considered uniform regarding climate, agricultural practices, pest situation and userecommendations, there may be an even greater variation of residues among areas ofwidely differing conditions (e.g. countries being in temperate, Mediterranean and
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tropical zones). The differences in use conditions can be so large that they result indifferent residue populations.
Frequently the situation is complex, even when copious data and information areavailable. There are alternative interpretations, and judgement is required to arrive at anestimate which is realistic, practical and consistent.
Although supervised residue trials are conducted according to GAP prevailing atthe time, GAP is often subsequently modified by changing the rate of application, type offormulation, method of application, number of applications and PHI. Judgement is thenrequired in order to determine whether the trial conditions are still close enough to GAPto be relevant.
The nominal rate of application in a trial would normally be considered stillconsistent with GAP when it is within ± 25-30% of the GAP rate, which includes theprobable variation in commercial practice. When little or no residue is present, data fromhigher applications may be important.
In many situations different formulations would cause no more variation thanother factors, and data derived with different formulations would be consideredcomparable. Experience from trials demonstrates that EC, WP and SC formulations leadto similar residues. On the other hand, controlled-release formulations would beexpected to lead to more persistent residues and would not be comparable to others.
The method of application can be quite influential on residue levels. For example,directed application is not comparable to cover spray, and aerial application may not becomparable to ground application.
For a non-persistent pesticide the number of applications is unlikely to influenceresidue levels: three, four or five applications could be considered equivalent from aresidue point of view. For a persistent pesticide the number of applications would beexpected to influence residue levels.
The nature of the crop should also be considered. For example, summer squashmay be harvested only a few days after flowering; residues of a non-systemic pesticideapplied before flowering would be expected to be low, and the number of applicationsshould have little influence on the residue level.
The pre-harvest interval usually, but not always, influences residue levels. In mostcases the PHI in supervised trials should agree with that specified by GAP . Whenresidue levels change rapidly it is not possible to extrapolate from one PHI to another;when they change slowly extrapolation is possible. For example, when residues of non-systemic pesticides in crops from trials are not detectable in samples taken before theprescribed pre-harvest interval, there is no reason to expect residues from samples takenaccording to the prescribed pre-harvest interval, as the residues in those samples alsowill be non-detectable. Furthermore, in the case of a relatively flat residue decline and
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typical horticultural or agricultural crop, data from a PHI range of 12-15 days could beconsidered equivalent. Normally, the range of PHIs whichgives ± 25-30% of the residue level obtained at registered PHI is consideredcomparable to GAP .. Residue decline data are useful in deciding the relative decline ofthe residue. Trials that do not conform to GAP can be used to provide information onpersistence. For example, there are cases where residues are not significantly influencedby the pre-harvest interval, so results obtained at intervals other than the specified PHImay be useful.
Some pesticide uses, such as seed treatments and pre-emergence herbicidetreatments, usually lead to non-detectable residues in the final harvested crop; but whenmany results are provided residues may be detected in occasional samples. Whileresidues resulting from use according to GAP are most likely to be undetectable, theoccasional detectable residues should not be ignored when a maximum residue level isestimated. Phorate on potatoes and residues arising from the pre-planting application ofglyphosate are two examples.
Greater certainty that the climatic conditions are properly reflected in thesupervised trials is afforded when the trials are carried out in a country with establishedGAP. Trials conducted in other countries with similar climatic conditions may beacceptable on a case-by-case basis. An assessment of those conditions is difficult, and acritical evaluation is needed as only some difference in conditions, such as temperature,may be of great importance for the persistence of many pesticides and consequently forthe residue level.
The trials should be carried out with the same crops as those specified in thenational GAPs. The proper description of the crops used in the supervised trials isimportant for deciding if crops referred to in GAP are in accordance with those forwhich trials have been carried out. The use of the Codex Classification for describing theharvested commodity facilitates the evaluation.
The CCPR establishes MRLs on commodities as they move in trade to enable thecontrol of compliance with and enforcement of GAP . Consequently, the maximumresidue levels are estimated on a whole commodity basis (see Appendix VI) as far aspractical.
In addition to residues in/on the whole commodity, the JMPR is also interested inresidues in the edible part of the crop. Residues of systemic pesticides may be expectedto be present in all parts of the crop, while residues of non-systemic pesticides are notalways present or may be present in minor quantities in the edible part of a crop. For eachpesticide, information on the distribution between edible and non-edible parts should beavailable to the JMPR from supervised trials or special experiments. This information isalso essential for deciding on the toxicological acceptability of residue levels on or incommodities consumed in substantial amount. For example, MRLs are established forwhole bananas including the inedible peel. Some MRLs may appear to be unacceptablyhigh based on residues on the whole commodity. However, information that residues onedible portion are practically non-detectable often alleviates that concern. Another
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example is oranges where usually most residues are present in the peel, especially fornon-systemic pesticides.
When estimating maximum residue levels, the FAO Panel examines all residuedata arising from supervised trials supporting/reflecting the reported GAPs. First theuniformity of residue population reflecting GAPs is considered. When there is a largegap in residue values, either from the coefficient of variation of residues in compositesamples or other appropriate statistical methods, the presence of different populationsmay be suspected. The residue data and trial conditions need more stringent analysisbefore the maximum residue level can be estimated. The maximum residue levelestimation is based either on all approved uses or on only those which lead to the highestresidues. In each case, a sufficient number of trials (residue data) reflecting a particularuse should be available to enable the estimation of maximum residue level. It followsthat, in case of suspected multiple residue populations, a few data indicating the highpopulation may not be sufficient to estimate a maximum residue level reflecting thatpopulation (and use pattern), and the FAO Panel may estimate a maximum residue levelreflecting only those uses for which sufficient residue data are available. On the otherhand, it is not possible to reconsider and reduce a previous estimate based on a few newtrial data, unless the GAP on which the old recommendation was based has been changedin the meantime or the original trials on which the MRL were estimated are nowconsidered inadequate.
The maximum residue levels are usually estimated taking into account the spreadof residues within the selected set of trials. Although the JMPR may use statistical tools,it has not routinely adopted standard statistical methods. There are several reasons forthis. One is the lack of internationally accepted standards for such an approach. A moreoperational reason is the nature and quality of the data usually available. (The number oftrials is generally too low to apply statistical methods to render a given probability andconfidence level to the estimated limits.) The form in which the residue data areprovided, for example, often does not lend itself to statistical analysis, while treatmentswhich involve more subjective judgements, such as taking into account data from similarcrops or the consideration of historical data, are difficult to fit into a statistical approach.Whenever the data base is suitable, the FAO Panel may also take into account statisticalconsiderations (e.g. in the 1996 Evaluations, aldicarb residues in potato and DDTresidues in meat).
5.4.1 Specific considerations in estimating maximum residue levels
Fruits and vegetablesWhen estimating maximum residue levels in fruits and vegetables all of the previouslydescribed general considerations apply. Applications on fruit and vegetables may takeplace at any stage of the developments of the plants and in the soil before and aftersowing, and the residue levels are highly dependent on the treatment.
The importance of PHI on residue levels has been described in section 5.4.
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The whole fruit residue may sometimes be derived from data obtained separatelyfrom peel and pulp if the weights of peel and pulp are available.
Grains and seedsThe Maximum Residue Limit for seeds or grains applies to the whole commodity. It isimportant for the JMPR to be able to distinguish between the forms in which thecommodities are present and to describe the raw and processed commodities accordingto the Codex Commodity Classification, as some grains and seeds are still in the husksand others are without husk. Sometimes residues are reported in polished rice. Theresidue levels are usually considerably different for those sorts of commodities. Theestimation of the maximum residue levels should be based on residues in commoditieswhich may move in international trade.
When grains and seeds are milled, the commodities belong to the processedcommodities.
Animal productsThe results of animal transfer studies and residues in animal feed and processing by-products of food serve as a primary source of information for estimating maximumresidue levels. In addition, animal metabolism studies may give useful information.
Uptake of pesticides by animals, leading to residues in animal products, can occurfollowing either direct application of the pesticide to the animal or its housing, oringestion of feed carrying residues of pesticides.
Animal feeds with residues of pesticides may derive from:• crops produced mainly for animal feed (e.g. pasture, straw, forage),• crops produced mainly for human food which are fed to animals (e.g. cereal
grains),• waste from crops grown primarily for human food (e.g. skins, pulp, stems,
stubble, trash),• animal feeds that have not themselves been treated, but in which unintentional
residues occur, as for example originating from soil treated in an earlierseason.
When the animals are fed, the potential for dilution of residues is considerable.Not all producers of the primary crop are likely to have used the same pesticidesimultaneously, and the pesticides used are not always used at their highest permitted userates nor at the nearest time to harvest. Consequently, the calculations based onmaximum intake and MRL values give an unrealistic overestimate of residue levels inanimal products.
Currently there are differences in national approaches to estimating residue levelsin animal products, and the subject is also under reassessment by the JMPR. Therecommended method of assessment will be published in future JMPR Reports. In thecase of pesticides which are excreted rapidly and where there is no build-up of residuesin the animal tissues, probably the best approach for making estimates of maximum
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residue levels is to use the median value of residues in feed items and the upper limit ofthe range in which a commodity might reasonably be fed. For other pesticides theestimated maximum residue levels should be taken into account. Examples of maximumproportions of agricultural commodities in animal feed in different regions are given inAppendix IX. In selecting the median residues, it is considered prudent to consider thoseuses and trials which represent the maximum potential for residues only and not all of thedata. The principles of estimating supervised trial median (STMR) values are describedin detail in section 6.2. In the case of processed feed items, it is preferable to useresidue data from commercial processing of field-treated crops containing residues atabout the expected maximum residues.
Certain pesticides are highly soluble in fat and are almost completely transferredinto fatty tissues, being distributed throughout the body fat. Assessment of fat-solubilityis based on the octanol water partition coefficient (see section 5.1.1) and the results ofmetabolism and animal transfer studies. If the pesticide is considered fat soluble thisshould always be indicated in association with the definition of residues.
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MeatFor pesticides which are not fat-soluble, the MRLs are estimated for the whole productas it moves in trade.
For fat soluble pesticides the maximum residue levels are estimated based onresidues in fatty tissues. For those commodities where the adhering fat is insufficient toprovide a suitable sample, the whole meat commodity (without bone) is analysed and themaximum residue level is estimated on the whole commodity basis.
Edible offalsThe maximum residue levels are estimated on a whole commodity basis.
Milk and milk productsFor milk it is known that the fat content varies widely between different breeds of dairycattle. In addition, there are a large number of milk products with varying fat content andit would be difficult to propose separate MRLs for each of them. It was thereforeoriginally decided to estimate MRLs for fat-soluble compounds for milk and milkproducts on a fat basis, i.e. the fat content of the sample should be determined and theresidue levels expressed as if wholly contained in the extracted fat.
Currently the JMPR follows the CCPR convention of expressing the MRL for fat-soluble compounds in milk on a calculated whole product basis, assuming all milks tocontain 4% fat. (The residue is calculated for the whole product based on the residuemeasured in the fat.) For compounds which are not fat-soluble, the analytical portion forenforcement purposes is whole milk and MRLs are expressed on a whole milk basis.
Details of expressing residues in milk and milk products are given in section 5.5.
EggsFor eggs, the maximum residue level is estimated on the basis of the whole commodityafter removal of the shell.
5.4.2 Estimation of group maximum residue levels
The establishment of commodity group MRLs as opposed to MRLs for individualcommodities has long been considered an acceptable procedure at both the national andinternational levels. The use of the approach is a recognition that economics may notjustify residue trials on all of the individual crops in a group. It also follows naturally innational registration systems where the registered use is on a crop group such as citrus.In principle the approach recognises that adequate data for the major crops of a groupmay be sufficient to estimate maximum residue levels for the whole group.
Some pesticides behave differently in different circumstances. Consequently, itis not possible to define precisely those commodities on which trials will always providedata which can lead to a group MRL. If the "highest residue" situation can be identified,however, the relevant data can be extrapolated to other crops with confidence. An
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acceptable example is extrapolation of residue data from gherkins to cucumber; however,the converse is not possible due to the higher residues that can be expected in gherkins asa consequence of their slower growth rate and the difference in weight/surface ratio.Extrapolation requires a detailed knowledge of agricultural practices and growth patterns.In view of the large differences in texture, shape, growth habits, rate of growth andseasonal cultivation and the significant role played by the surface/weight ratio, the JMPRhas emphasised that decisions to extrapolate should be made on a case-by-case basiswhen adequate relevant information is available.
The JMPR has proposed group MRLs since 1966. Historically the JMPR hasalways approached the issue of group or individual MRLs on a case-by-case basis and thatapproach is unchanged. The main reasons for this are the many factors which can affect adecision on whether or not to propose a group MRL and the lack of internationalconsensus on criteria. These considerations have prevented the JMPR from developingspecific guidance for estimating group MRLs which might be applied at the internationallevel in all situations.
Although such specific guidance is not yet available, some general guidance hasbeen developed and recorded by the JMPR over the years. The development of the CodexClassification provided an important aid for estimating group maximum residue levels.
The 1996 JMPR took into account its previous considerations of the issue aswell as the collective experience of its members, and summarised a number of generalprinciples and observations which reflect the current views of the JMPR on estimatinggroup MRLs.
(a) The JMPR continues to rely on the Codex Classification of Foods and Feeds as theprimary basis for recommending MRLs for individual or grouped commodities.
(b) Generally the JMPR now refrains from estimating maximum residue levels for largeCodex ‘classes’ of foods or feeds such as fruits, vegetables, grasses, nuts and seeds,herbs and spices, or mammalian products. Residue data and approved uses are usuallymore likely to refer to smaller Codex ‘groups’ such as pome fruits, citrus fruits, rootand tuber vegetables, pulses, cereal grains, cucurbit fruiting vegetables, milks, meatof cattle, pigs and sheep, etc. As well as being more likely to be justified by theavailable data on residues and information on GAP , this is judged to be more in linewith national approaches and affords more accurate estimates of dietary intake.
(c) When adequate residue data are available for only a few primary commodities in afood group, separate MRLs should generally be recommended for each commodityon which the data are considered adequate.
(d) In some cases the JMPR may, in the absence of sufficient data for one commodity,use data from a similar crop for which GAP is similar to support estimates ofmaximum residue levels (e.g. pears and apples or broccoli and cauliflower).
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(e) If other considerations permit, data on residues in all or most of the majorcommodities with the potential for high residues within a group may allow estimatesof maximum residue levels to be extrapolated to minor crops in the group. Anexample of a situation in which other considerations do not permit this is that inwhich the variability of the residue levels is too great, even though data on the majorcrops within the group are available. A group limit cannot then be established.
(f) When residue levels in a number of commodities in a group vary widely, separaterecommendations should be made for each commodity. A limit for a group ‘exceptone or more commodities’ which are known to deviate from the norm may bejustified (e.g. citrus fruits, except mandarins); in such cases separate MRLs shouldbe estimated for the exceptional commodities.
(g) In order for a group limit to be proposed, not only must residue levels in the majorcommodities in the group not be too different, but the physical nature and othercharacteristics of the crops that might influence residue levels, as well as culturalpractices and GAP for the individual commodities, must also be taken into account.
(h) Residue data for a crop growing quickly in summer cannot be extrapolated to thesame or related crops growing slowly under less favourable conditions (e.g. fromsummer to winter squash).
(i) In establishing group MRLs, detailed knowledge of the metabolism or mechanism ofdisappearance of a pesticide in one or more crops must be taken into account.
(j) Group MRLs recommended by the JMPR that generally appear to be acceptableinclude those for cereal grains (based on data for maize, wheat, barley, oats and ricewithout specific data on millet, rye or sorghum), pome fruit, based on apples andpears, extrapolated to quinces; stone fruits, poultry meat, milks, meat from mammalsother than marine mammals, and oilseed.
(k) A group MRL is generally preferred in the case of citrus fruits, but care must be usedin estimating a maximum level for the group because of the large variations in fruitsize and in the ratio of peel to pulp in view of the propensity for residues of manypesticides to concentrate in the peel. Data on major members of the group areespecially important.
Historically, as of the time of availability of these guidelines, many more Codexlimits have been established for citrus fruits as a group (45 pesticides) than forindividual citrus fruits (19 pesticides): lemons (2 pesticides); lemons and limes (1);mandarins (4), sweet and sour oranges (8), sweet oranges (1); shaddocks or pomelos(1); and grapefruit (2).
(l) All else being equal, data on a crop picked when immature may sometimes beextrapolated to a closely related species with a lower surface area/weight ratio at thetime of the pesticide application which grows quickly to maturity, resulting in a rapid
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decrease in the ratio of residue to crop weight (dilution by crop growth). Thus,estimated maximum residue levels can be extrapolated from gherkins to cucumbers,but not vice versa.
(m) Individual MRLs can be extrapolated more readily to groups when there is noexpectation that terminal residues will occur and when this is supported by studies ofmetabolism. Examples are early treatments, seed treatments and herbicidetreatments of orchard crops.
While the JMPR generally adheres to these principles on a case-by-case basis, itrecognises certain difficulties or limitations in the acceptance of group limits at theinternational level. A primary weakness is the lack of formal criteria or an agreedmechanism to determine the members of a group for which data are needed before agroup MRL can be established. One approach that is sometimes used effectively at thenational level is to identify commodities of a group (often botanical) that represent bothmajor crops within the group and those most likely to contain the highest residues. Thefactors used to determine whether a crop is a major or representative member of thegroup include its dietary significance as a food or feed.
The premise of this approach is that if data are available for representative crops,and if GAP and cultural practices among the individual members are similar, the residuelevels will not vary widely and a maximum residue level can be estimated that will sufficefor other members of the group for which no data are available. As noted earlier, thisapproach constitutes the use of common sense and is more or less dictated by theeconomics of data generation and evaluation.
While the JMPR recognises real advantages in this approach, there isunfortunately no consensus at the international level on the selection of representativecommodities for estimating maximum residue levels for groups. Similarly, while theJMPR bases its recommendations on the Codex Classification of Foods and Feeds, thisclassification has not been fully adopted at the national level in most countries.
Until there is more international agreement in this area, the JMPR will continueto make judgements on a case-by-case basis, using the general policy summarised aboveor as it may be subsequently amended.
5.4.3 Estimation of extraneous residue levels (ERL)
Chemicals for which ERLs are most likely to be needed are those which have beenwidely used as pesticides, which are persistent in the environment for a relatively longperiod after uses have been discontinued and which are expected to occur in foods orfeeds at levels of sufficient concern to warrant monitoring.
Predictions of persistence in the environment (and the potential for uptake byfood or feed crops) can often be based on a combination of data sources normallyavailable for chemicals previously approved as pesticides. These may include
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information on their chemical and physical properties, metabolism studies, data onsupervised field trials, data on environmental fate, rotational crop data, the knownpersistence of similar chemicals, and especially from monitoring data.
In order to make reasonable estimates to cover international trade, the JMPRneeds all relevant and geographically representative monitoring data (including nilresults). Better ERL estimates, taking into account trade concerns, can be made whenmore extensive data are available. However, typically data are available from only threeor four (usually developed) countries at the most. By the nature of national monitoring,data are usually received primarily on those commodities in which residues have beenfound at the national level and which have the potential to create trade difficulties.
On receipt of the data, to the extent possible the JMPR attempts to take intoaccount a number of factors in estimating an ERL. These include the amount of data, therelative importance of the commodity in international trade, the potential for tradedifficulties or accounts thereof, the frequency of positive results, a knowledge of thepropensity of a particular crop to take up residues (e.g. the uptake of DDT by carrots),historical monitoring data (e.g. previous monographs), and the level and frequency ofresidues in similar crops, especially those in the same crop group. In some cases theestimate has turned out to be the highest level reported, especially if a relatively gooddatabase is available and the spread of results is reasonably narrow.
In recent years there have been cases where the ERL was estimated below thehighest residue found, especially if the higher values occur infrequently. For example,the 1993 JMPR recommended an ERL of 0.2 mg/kg for DDT in carrots, although 2 of 4imported samples reported from one country were 0.4 and 0.5 mg/kg. The JMPR tookinto account that only 2 of over 800 imported samples exceeded 0.2 mg/kg. This limitcovers > 99% of the residue population with 99% confidence. A similar approach wastaken for DDT in the fat of meat by the 1996 JMPR. This approach also recognises thatresidues gradually decline and that monitoring data are often somewhat out-of-date bythe time they reach the JMPR. It is more likely to be used when the higher residuesoccur infrequently.
In the context of ERLs, the JMPR does not consider extreme values to beoutliers in a statistical sense, because high residue levels are usually not true statisticaloutliers but values on one tail of a large distribution. The challenge is to decide when it isreasonable to discard those values in order to reflect the expected gradual decline in thelevels of chemicals that are typically subject to ERL estimates, while not creatingunnecessary barriers to trade.
Generally, the JMPR considers that the databases needed for estimating ERLsshould be significantly larger than those required for the estimation of MRLs, becausethe ERL data are very far from normal distribution. For example, samples from 598randomly selected animals are needed to ensure that the estimated ERLs cover 99.5% ofa population, allowing a 0.5% violation rate with 95% confidence (Codex Alimentarius,Vol. II, 2nd Ed., p. 372). On the other hand, if a country had only 100 random samplesanalysed with a 10% violation rate this is quite significant, despite the small number of
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samples. As ERL databases are derived from the random monitoring of differentpopulations, the JMPR does not normally consider a ‘world’ population of data, but givesindependent consideration to different populations, e.g. of different geographical regionsor of different animals, before deciding which data populations might be combined.Therefore, all relevant monitoring data should be submitted regardless of the number ofsamples analysed.
The JMPR compares data distribution in terms of the likely percentages ofviolations that might occur if a given ERL is proposed. Since there is no internationallyagreed level of acceptable violation rate, the JMPR estimates ERLs based on theavailable data. However, violation rates of 0.5 to 1% or greater are generally consideredunacceptable.
It is to be expected that there will be a gradual reduction and/or elimination ofresidues of the chemicals for which ERLs have been proposed. The rate will depend on anumber of factors, including the nature of the chemical, the crop, the location andenvironmental conditions.
The JMPR intends to continue lowering the ERLs as the results of monitoringpermit. The aim of lowering ERLs is to discourage unauthorised uses which higherlevels might accommodate, and it is hoped to encourage those who might not otherwisesubmit data to do so.
Because residues gradually decrease, the JMPR recommends reassessment ofERLs about every 5 years. Eventually, the data may indicate that there is no longer a needto monitor the chemical. This view would be based on the conclusion that there is nolonger a potential for significant disruption of trade and that the incidence or level ofresidues is no longer a significant health concern.
Although the JMPR does not use targeted monitoring data for estimating ERLs, itagrees that follow-up studies are important when high residues are found in randommonitoring to give a clearer view of the significance of the high levels. If properlyconducted, such studies may indicate whether or not the higher residues resulted fromintentional unauthorised uses and may allow the identification of areas in whichproduction should be limited or where residue reduction strategies should beimplemented.
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5.5 Expression of Maximum Residue Limits
The estimated maximum residue levels and recommended residue limits are expressed inmg residue (as defined)/kg commodity. The portion of commodity to which CodexMRLs apply is given in Codex Alimentarius Vol. 2 (extracted in Appendix VI).
The residues are expressed on fresh-weight basis or as they enter internationaltrade (as received by the laboratory) in most commodities, with the exception of animalfeeds. Because of the great variation of their moisture content, MRLs for animal feedsare recommended on a dry-weight basis, and this implies that the commodity is analysedfor pesticide residues as received, that the moisture content of the sample is determined,preferably by a standard method recommended for use on that commodity, and that theresidue content is then calculated as if it were wholly contained in the dry matter.
If it is not clear in animal feed residue data submissions whether residues areexpressed on a dry weight basis, or the moisture content of the feed is not reported, thedata may not be suitable for estimating maximum residue levels (See also 3.1.5.1).
For animal products there are certain special cases which need to be mentioned:
For meat and fat soluble pesticides (see section 5.1.1) the residue limits areproposed on a fat basis (the residue content in fatty tissue or fat cut off meat) which isindicated in brackets (fat) after the residue value. For those commodities where theadhering fat is insufficient to provide a suitable sample, the whole meat commodity(without bone) is analysed and the MRL applies to the whole commodity.
For all other pesticides the MRLs apply to the whole product as it moves in trade.
The MRLs and EMRLs for fat-soluble pesticide residues in milk and milkproducts are expressed on a calculated whole product basis assuming all milks to contain4% fat. Milk products with a fat content of 2% or more are expressed on a fat basis. TheMRL would be 25 times the MRL for milk. The MRL for milk products with a fatcontent lower than 2% are considered to be half the value for milk and are expressed on awhole product basis.
Milk MRLs for fat-soluble pesticides are indicated by the letter “F”
When the recommended limit is based on veterinary use (direct animal treatment)this fact is indicated by the letter ”V” after the limit.
Examples for recommended MRLs (mg/kg) for diazinon -MO 0098 Kidney of cattle, pigs and sheep: 0.03 VMM 0097 Meat of cattle, pigs and sheep: 2 (fat) VML 0106 Milks 0.02 F V
MRLs reflecting special uses or conditions are also distinguished by letters afterthe limit: Currently the following cases are distinguished by the letters indicated below:
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E The MRL is based on extraneous residues Po The MRL accommodates post-harvest treatment of the commodity PoP The MRL accommodates post-harvest treatment of the primary commodity T The MRL/EMRL is temporary, irrespective of the status of the ADI, until
required information has been provided and evaluated.
For the numerical expression of the limits, the following scale is used usually:0.01, 0.02, 0.05, 0.1, 0.2, 0.5, 1, 2, 3, 5, 10, 15, 20, 30, 50 and 100 mg/kg. Othervalues could be used if necessary for special reasons.
In general, it has been shown that the expectable minimum coefficient of variationof residue results of supervised trials is around 30-40% (Ambrus, 1996a); therefore,MRLs below 10 mg/kg should be expressed to only one significant figure to reflect theinevitable variation of analytical results, incorporating the uncertainty of sampling,sample preparation and analysis.
5.5.1 Expression of Maximum Residue Limits at or about the limit of determination
The limit of determination (LOD) is the lowest concentration of a compound that can bedetermined in a commodity with an acceptable degree of certainty.
The JMPR recognised the difficulties that may arise in regulatory laboratoriesanalysing low level of residues in samples of unknown origin, and stated that it usuallyestimates a limit of determination which is achievable under those conditions. It is thisfigure that is proposed as a maximum reside limit “at or about the limit ofdetermination”. These limits are indicated with an asterisk (*) after the numerical value(e.g. 0.02*). This limit is often referred to as a “practical limit of determination” todistinguish it from the limits of determination reported in supervised trials.
An MRL so identified does not always necessarily imply that residues of thepesticides do not occur in that commodity. The application of a more sensitive orspecific method may reveal detectable residues in some commodities as shown, e.g. inTables 14 and 26 of the 1995 monograph on quintozene.
In many instances the use of a pesticide according to GAP results in a residuelevel in crops or commodities that is too low to be measurable by available analyticalmethods. Setting and enforcing MRLs for residues occurring at or about the limit ofdetermination of analytical procedures may require different approaches depending onthe composition and definition of the residues. It is emphasised that all availablerelevant information should be carefully considered to ensure that an MRL establishedat a level equivalent to a practical limit of determination of the individual residuecomponents will fully accommodate the levels of these components which could occurin commodities following treatment according to GAP.
As in cases of detectable residues, the definition of residues at or about the limitof determination may also include a single residue component (e.g. fenpropimorph in
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sugar beet) or several residues components (e.g. aldicarb, its sulphoxide and itssulphone expressed as aldicarb in peanut oil, bentazone, 6-hydroxy bentazone and 8-hydroxy bentazone expressed as bentazone in soya bean; and fenthion, its oxygenanalogue and their sulphoxides and sulphones expressed as fenthion in potato).
In cases where several metabolites are included in the definition of the residuetwo basic situations can be distinguished.(1) The residue components are or may be converted to a single compound or analyte by
the analytical method (e.g. fenthion). The total residue is measured as a singlecompound and expressed as the parent compound (e.g. fenthion sulfone is measuredand expressed as fenthion). The MRL is set and enforced on the basis of the totalmeasured residue. Since, after the conversion of all the residue components a singlecompound is to be determined, the MRL can be simply enforced either at or abovethe LOD. This situation is similar to other cases where the residue is defined as asingle compound.
(2) The residue components are determined separately by the method. Theconcentrations of measurable residues are adjusted for molecular weight andsummed, and their sum is used for estimating the maximum residue level.
The problem is best illustrated with an example. The residues of bentazone inplant commodities are defined as the sum of bentazone, 6-hydroxybentazone and 8-hydroxybentazone, expressed as bentazone. The LODs reported in supervised trials foreach of the three components were generally 0.02 mg/kg, but the practical LODs wereregarded as 0.05 mg/kg for regulatory purposes. If an MRL for bentazone was set as thesum of the practical LODs of the three components of the residue, it would have to beestablished at 0.2 mg/kg (3 times the practical limit of determination to incorporate allthree residue components). In this case, any one of the residue components could bepresent at 0.2 mg/kg, or all of the three at 0.06 mg/kg, without exceeding the MRL.Consequently, individual residue components could be respectively 10 and 3 timesthose which should arise from the recommended use of the compound but would bewithin the MRL. Similarly, if the sum of the LODs achieved in the supervised trials wasconsidered, an MRL of 0.1 mg/kg would be needed, which would still allow 5 times theresidue that would arise from treatments complying with GAP .
The 1995 JMPR concluded that when residues are undetectable in a commodityan MRL based on the sum of the LODs of the individual residue components is notappropriate for enforcement purposes.
The JMPR considered some of the situations which occur under practicalconditions and used the examples to explore the possible actions in order to facilitatethe elaboration of an internationally acceptable procedure.
The comments of Codex member countries on the approach recommended by theJMPR and information on their national practice were requested by the CodexSecretariat. The JMPR will consider the comments in the further development of theprinciples.
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5.6 Recommendations for Maximum Residue Limits
The JMPR recommends to the CCPR that the estimated maximum residue levels be usedas MRLs if the toxicological evaluation of the compound enabled the estimation of anADI.
In those cases where a full ADI could not be estimated or the previously estimatedADI has to be withdrawn, the JMPR does not recommend MRLs. However, the estimatedmaximum residue levels may be used as Temporary MRLs or Guideline Levels.
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5.6.1 Recommendation of Temporary MRLs
A temporary maximum residue limit is a maximum residue limit for a specified, limitedperiod, which is clearly related to required information.
As a general policy, TMRLs will not be introduced for a new compound, acompound in the periodic review programme or when there is no established GAP .
Temporary MRLs may be recommended when some information, which is stilllacking, is unlikely to affect the validity of the estimated maximum residue level andthere is a clear commitment that the information will be available by a specified date.
The JMPR may recommend a TMRL in some special circumstances, decided on acase-by-case basis, for example:
• The JMPR is informed that experiments are in progress and data fromresidue or processing trials will be available for a specified Meeting in thefuture.
• Immediate withdrawal of an MRL may be too disruptive if insufficientopportunity has been given for comment and data submission.
The JMPR may also recommend conversion of an MRL to a TMRL when there isa significant change in GAP which would affect residue levels. The JMPR would requirecomplete information to be supplied by a specified date.
TMRLs for specific commodities may be used to replace group commodityMRLs or "fruit" and "vegetable" MRLs where it is known that residue trials on thosespecific commodities are in progress. Such a situation has arisen when a group MRL hasbeen scheduled for review and residue data are being developed for some commodities inthe group. It would not be correct to withdraw the group MRL without introducing somerecognition of the continued validity of maximum residue levels estimated for thosecommodities while the work is in progress. In the absence of other information, theTMRLs would be recommended at the same level as the group MRL to be withdrawn.
Each recommended TMRL will be directly related to an item of requiredinformation. Each such item will have a due date specified. The information is to beavailable for review at the Joint Meeting in the year specified. If the required informationis not supplied by the due date, the TMRL will be withdrawn.
The FAO Panel applies the same principles for estimation of maximum residuelevels for TMRLs as those followed for estimating maximum residue levels forrecommending MRLs.
5.6.2 Estimation of Guideline Levels
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A Guideline Level is the maximum concentration of a pesticide residue occurring afteruse of the pesticide according to Good Agricultural Practice, but for which noAcceptable Daily Intake has been established or it has been withdrawn by the JMPR.
There may still be a need to inform regulatory authorities about the residue levelsto be expected in food items when these pesticides are used in accordance with GoodAgricultural Practice.
Over a number of years the Codex Committee established a list of so-called"Guideline Levels" for pesticides. These Guideline Levels had not been submitted to theCommission for adoption, but were used for the internal reference of the Committee. In1993 the Codex Alimentarius Commission decided that Guideline Levels would nolonger be established. The existing Guideline Levels had been submitted to a reviewprogramme in order to delete compounds from the list.
The FAO Panel continues to estimate maximum residue levels for variousresidue/commodity combinations based on the same principles, regardless of the statusof ADI. Thus, the estimated limits can be recommended for use as Codex MRLs when anADI has been established.
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6. ESTIMATION OF RESIDUE LEVELS FOR CALCULATION OF DIETARY INTAKEOF PESTICIDE RESIDUES
Joint Meetings are held in order to evaluate the possible risk to consumers arising fromthe occurrence of residues of pesticides in foods. As long as the residues of a certainpesticide, taken up by the consumer, do not exceed the ADI the safety of the consumer isconsidered to be adequately protected. The JMPR combines available residue data withcultural dietary information to make predictions of the residue intake.
6.1 Guidelines for predicting dietary intake
The JMPR has, from the beginning, tried to arrive at predictions about the intake ofpesticide residues on the basis of available data. In taking the MRL as the residue leveland using the dietary patterns for the quantity of food consumed, the JMPR arrived at theTheoretical Maximum Daily Intake or TMDI. The JMPR was well aware of the fact thatTMDI calculations result in a gross overestimation of the intake. On the other hand,existing uses of the pesticide not brought to the attention of the JMPR could result in aminor underestimation of the residue intake.
Until recently the dietary intake calculations have been carried out according tothe Guidelines for predicting dietary intake of pesticide residues published by WHO in1989. The dietary intake of any particular pesticide residue is obtained by multiplying theresidue level in the food by the amount of commodity intakes from a "global" and five"cultural" diets, also called "regional" diets. Total intake of the pesticide residue in eachof the diet groups is then obtained by summing the intakes from all commoditiescontaining the residue concerned. The correction factors include the residue level in theedible portion of the commodity, the reduction or increase of the residues oncommercial processing such as canning and milling, and the reduction or increase in thelevel of residue on preparation or cooking of the food. This leads to the EstimatedMaximum Daily Intake or EMDI. According to the Guidelines, EMDI calculations shouldonly be carried out when the TMDI exceeds the ADI for a pesticide. However, the EMDIis still based on the assumption that all crops have been treated with the pesticide inquestion and with residues in the raw commodity at a level corresponding to the MRL,and this will also give rise to an overestimate of the intake.
The guidelines also described a more realistic intake calculation, the so-called Estimated Daily Intake or EDI. In this calculation, several reduction factors aretaken into account which are only available at national levels. EDI calculations weretherefore only to be carried out at a national level by those with adequate information onfood consumption, the use of a given pesticide locally, and the nature and the amount ofimported food.
Based on the request of the CCPR a Joint FAO/WHO Consultation on Guidelinesfor predicting the Dietary Intake of Pesticide Residues was held in York, UnitedKingdom, 2-6 May 1995. Its main objectives were to review the existing guidelines and
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to recommend feasible approaches for improving the reliability and accuracy of methodsfor predicting the dietary intake of pesticide residues to promote a greater acceptance ofCodex MRLs by governments and, most importantly, by consumers. The report of theconsultation (WHO/FNU/FOS/95.11) contained recommendations for improvingestimates of dietary intake, most notably the use of supervised trials median residue(STMR) levels in lieu of MRLs in the calculation of International Estimated DailyIntakes (IEDIs) and National Estimated Daily Intakes (NEDIs).
The IEDI incorporates those factors which can be applied at international level andwhich comprise a subset of the factors that might be considered at national level. Thefactors to be considered for IEDI calculations are:
• Median residue data from supervised trials (not on MRLs);• Residue definitions, which include all metabolites and degradation products
of toxicological concern;• For residues at or below the limit of determination (indicated with *), the
median residue should be estimated to be the LOD except when evidencefrom trials and supporting studies suggests that that residues are essentiallyzero;
• The edible portion;• Effects on residue levels due to storage, processing or cooking practices;• Other known uses of the pesticide.
The National Estimated Daily Intake (NEDI) should be based on the same factorsas for the IEDI, but the following additional factors based on national use pattern of thepesticides and food consumption data should also be taken in consideration, which wouldresult in a refinement of NEDI:
• Proportion of crop or food commodity treated;• Proportion of crop domestically produced and imported;• Compliance monitoring and surveillance data;• Total diet (market basket) studies;• Food consumption data, including that of subgroups of the population.
The revised guidelines for intake calculations are under preparation by the WHOSecretariat.
According to those recommendations where TMDI calculations are carried out bythe JMPR, they should be based on "cultural" diets rather than the "global" diet, and somechanges were proposed in the calculation system. However, the Consultation emphasisedthat the best use should be made of all available data and recommended that calculationsof EMDIs should be discontinued to promote calculations of International EstimatedDaily Intake (IEDI) and National Estimated Daily Intake (NEDI). The recommendedprocedure is illustrated in Figure 6.1.
A further Joint FAO/WHO Consultation on Food Consumption and ExposureAssessment of Chemicals will be held in 1997 at WHO Headquarters in Geneva. TheConsultation will follow up certain recommendations of the York Consultation,
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particularly in the development of regional diets and in addressing issues related toimplementation of the recommendation on intake assessment for acute hazards.
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Figure 6.1. Scheme for assessment of dietary intake of pesticide residues for chronichazards
Evaluate data, establish ADI, propose MRL
International level National level
The JMPR will continue the estimation of TMDIs for (old) pesticides where dataare not available for estimating IEDIs, but emphasised that when information wasavailable a better estimate of intake should be derived from the IEDI method.
6.2 Estimation of supervised trial median values
As a consequence of the recommendations made by the Joint FAO/WHOConsultation for Predicting Dietary Intake of Pesticide Residues an informal Workshopwas convened in the Hague, Netherlands, in April 1996 to consider the effect of therecommendations on the work of JMPR and especially of those related to the reviews ofresidue data undertaken by the FAO Panel members. At this Workshop, guidelines weredeveloped in order to give guidance on the implementation of the York Consultationrecommendations to the FAO Panel reviewers, and to convert the recommendations intopractical methods for evaluating data.
The Workshop focused on the reviews of data undertaken by FAO Panel membersand the estimation of supervised trials median residue (STMR) levels. Several generalrecommendations and 27 specific recommendations for the evaluation of data weremade.
Calculate TMDI andcompare with ADI
Calculate NTMDI andcompare with ADI
Calculate IEDI andcompare with ADI
Calculate NEDI andcompare with ADI
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Comparability
Residues data from countries are evaluated against the GAP in the country of the trials ora neighbouring country with similar climate and cultural practices.
In identifying the STMR, the trials values selected should be comparable with themaximum registered use (i.e. maximum application rate, maximum number oftreatments, minimum PHI) on which the MRL is based.
In establishing comparability of uses in the residue trials to the maximumregistered use, the application rates in the trials should generally deviate no more than±25-30% of the maximum application rate. Deviations from this should be explained inthe appraisal. Similarly, maximum deviations of no more than ±25-30% should also beused as a guide for establishing comparability of PHI; however, in this case the latitudeof acceptable PHIs will also depend on the rate of decline of residues of the compoundunder evaluation. Consideration of whether the number of treatments reported in trials iscomparable to the registered maximum number of treatments will depend on thepersistence of the compound and the interval between applications. Nevertheless, when alarge number of treatments are made in the trials (more than 5 or 6), the residue levelshould be considered very little influenced by further treatments unless the compound ispersistent or the treatments are made with unusually short intervals.
In establishing comparability of residue trials data in which more than oneparameter (i.e. application rate, number of treatments or PHI) deviate from the maximumregistered use, consideration should be given to the combination effect on the residuevalue which may lead to an underestimation or overestimation of the STMR. Forexample, a trial result should not normally be selected for the estimation of the STMR ifboth the application rate is lower (perhaps 0.75 kg/ha in the trial; 1 kg ai/ha GAP) thanthe maximum rate registered and the PHI is longer (perhaps 18 days in the trial, 14 daysGAP) than the minimum registered PHI, since these parameters would combine tounderestimate the residue. When results are selected for the estimation of STMRs,despite combination effects, the reasons should be explained in the appraisal.
If the residue value arising from a use considered comparable with the maximumregistered use is lower than another residue value from the same trial which is withinGAP, then the higher residue value should be selected in identifying the STMR. Forexample, if the GAP specified a minimum PHI of 21 days and the residue levels in a trialreflecting GAP were 0.7, 0.6 and 0.9 mg/kg at 21, 28 and 35 days respectively, then theresidue value of 0.9 mg/kg would be selected.
Trials with more than one residue value
In identifying the STMR only one data point should be taken from each trial (i.e. in thisaspect, treatments carried out within a study at the same location with differentformulations, or different dosage rates or with the same dosage but at a different time,are considered to be different trials).
Where several residue values have been reported from replicate plots from asingle trial (i.e. same dosage at one site location), the highest residue should be selectedfor the purpose of identifying the STMR.
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Where several residue values have been reported from replicate analyses of thesame field sample taken from a single trial (i.e. site location), the mean residue shouldbe selected for the purpose of identifying the STMR.
Rounding of results
In identifying the STMR from a residue trial, the actual residue value should be used inthe estimation of dietary intake without rounding up or down. This would even be thecase where the actual results were below the practical limit of determination consideredappropriate for enforcement purposes. Rounding of residue values is inappropriate sincethe STMRs are used at an intermediate stage in the dietary intake calculation.
Residue definition
The WHO Panel considers and indicates in its evaluations which metabolites should beincluded in the dietary risk assessment.
If it is recommended that the residue definition for the risk assessment bedifferent from that for enforcement, this is clearly stated in the appraisal.
Close communication should be established prior to the JMPR meeting betweenthe FAO Panel reviewers and the respective reviewers on the Toxicological andEnvironmental Groups, on questions such as which metabolites are of toxicologicalsignificance.
In tabulating the residue trials data the FAO Panel reviewer should indicate thelevels of relevant metabolites separately from those of the parent compound, but in a waywhich would allow subsequent combination, in order to ensure that changes in the residuedefinition can be accommodated at the JMPR meeting.
In those cases where it is not possible to finalise the risk assessment at the JMPR(September, year 1), usually because of a change in residue definition, the MRLs wouldstill be recommended to the CCPR (by way of Codex circular letter for comment at step3) and the compound would be re-discussed at the following year’s JMPR meeting(September, year 2). The recommended MRLs together with the conclusion of the riskassessment would be available for the next CCPR (April, year 3).
If two compounds for which STMRs can be calculated produce the same analyte incompliance monitoring (e.g. CS2 for dithiocarbamates), it is possible to separate theintake assessments, if required, because the intake assessment is no longer based on theMRL but is based on residue data specific to the individual compounds.
Combining of populations of data for the calculation of STMRs
In identifying the STMR, residue data reflecting different countries’ GAPs wouldnormally be combined. However, if the trials data reflecting different countries’ GAPsappear to give rise to different populations of data then these data sets should not becombined. In these cases the STMR should be calculated from the population(s) of datawhich is (are) driving the MRL. In deciding whether the results of trials reflectingdifferent countries GAPs give rise to different populations of residues data, the size ofthe database reflecting the different countries’ GAPs should be taken into account.
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Residues below the limit of determination
As a general rule, where all residue trials data are <LOD, the STMR would be assumed tobe at the LOD, unless there is scientific evidence that residues are "essentially zero".Such supporting evidence would include residues from related trials at shorter PHIs,exaggerated, but related, application rates or a greater number of applications,expectations from metabolism studies or data from related commodities.
Where there are two or more sets of trials with different LODs, and nodeterminable residues have been reported in the trials, the lowest LOD should normallybe used for the purpose of STMR selection (unless the residues can be assumed to beessentially zero as given above). The size of the trials database supporting the lowestLOD value should be taken into account in the decision.
Processing, cooking factors and edible portion residue data
In using data on the effects on residue levels of processing or cooking practices, themean processing factor should be applied to the STMR estimated for the raw agriculturalcommodity as already described. The STMR value estimated in this way for theprocessed commodity should be referred to as the STMR-P.
If data are available for the residues in the edible portion of the commodity (e.g.banana pulp), a STMR should be estimated directly using the edible portion residuevalues from maximum registered use trials (as opposed to using pesticide values for thewhole commodity).
Acute dietary intake2
For the purpose of acute risk assessment the MRL, or the highest residue in the edibleportion, should be used in estimating dietary intake.
Estimation of MRLs for products of animal origin2
In estimating MRLs for products of animal origin, theoretical feed intakes for domesticanimals should be calculated using the STMR for each feed item (derived fromsupervised trials comparable with the maximum registered use), rather than the MRL,together with the maximum feed incorporation rates. This is in conformity with pastJMPR decisions.
Estimation of STMRs for commodity groups
Where there are adequate trials data the STMRs should, in principle, be identified for theindividual commodities and these values used for the intake assessment. However, wherethe MRL has been established for a group of commodities (e.g. pome fruit) a singleSTMR should be calculated for the group of commodities.
Presentation of STMRs in the JMPR monographs and report
The GAP(s) on which trials data have been selected for the purpose of identifying theSTMR should be clearly identified in the monographs.
In tabulating trials data in the monographs the reviewer should ensure that, inaddition to the normal underlining of trials data that are within GAP (and therefore have 2 The estimation of acute dietary intake and MRLs for products of animal origin are currently underreconsideration by FAO, WHO and the JMPR.
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been used for the MRL evaluation), the single residue values selected for the estimationof the STMR are double- underlined.
Information on the residue values on which the STMR is based should not only beidentified in the tabulated trials data (see above) but a list of the residue values selectedshould be included in the appraisal, in numerical order, with the median residueunderlined. Where the residue situation is complex (e.g. a number of metabolites to beconsidered) these data may best be tabulated in the appraisal. In addition, the STMRvalues should be included in the recommendation table in the appraisal and in Annex 1 ofthe report.
The range for the rates and PHIs used in the selection of residue values for STMRshould be clearly identified in the appraisal (e.g. trials data with application rates from1.8 - 3.0 kg ai/ha have been selected).
Methods for presenting estimated STMR levels are still being developed. The aimis to communicate the results as clearly and unambiguously as possible; experience mayindicate that further changes are necessary. As pesticides are used in a wide variety ofsituations, methods for evaluating data must be developed to take into account cases thatare not already covered by the suggested procedures. For instance, the recommendationson the estimation of STMRs in animal commodities arising from residues in feed, acutedietary intake and ectoparasite treatments of farm animals may require furtherdevelopment. Further guidance will be developed at future meetings of JMPR.
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7. USE OF JMPR RECOMMENDATIONS BY REGULATORY AUTHORITIES
The summaries and evaluations contained in the reports and evaluations are, in mostcases, based on unpublished proprietary data submitted for the purpose of the JMPRassessment. In this context the JMPR documents are a unique source of information.Regulatory authorities and other interested specialists are encouraged to make use ofthe critical evaluations of the JMPR.
7.1 Safety assessment of pesticides
The JMPR monographs and reports should be of help to FAO and WHO Member Statesin the safety assessment of pesticides and their residues. However, two major problemsare encountered when some Member States attempt to use these assessments: (1) theJMPR assesses the toxicology of active ingredients and not formulations, which arecontrolled at the national level, and (2) relationships between the purity andspecifications of the active ingredients that were tested and evaluated by the JMPR andtechnical materials of commerce are often unknown.
The purity of technical active ingredient depends on, among others, the route andconditions of synthesis, the purity of raw materials used for the manufacture, and thepacking and storage conditions. The toxicity of certain impurities can be severalmagnitudes higher than that of the active ingredient, and therefore their presence even invery small concentrations may substantially affect the toxicity of the pesticide product.
The Joint Meeting evaluates toxicological studies on test materials that in mostcases correspond to active ingredients that are sold by the company(ies) which providedthe data. The purity and specifications of active ingredients that regulatory authorities areasked to approve may or may not correspond to those that were tested and summarised inthe JMPR monographs. For this reason, registration authorities should carefullyconsider the extent of similarity between any active ingredient being considered forregistration and the technical material assessed by the Joint Meeting. To be able to makethis determination, registration authorities should seek information on manufacturingimpurities in pesticide products, as emphasised in Sections 6.2.2 and 6.2.3 of the FAOInternational Code of Conduct on the Distribution and Use of Pesticides. The safety of othercomponents of formulations should, of course, also be considered when registeringpesticides. For these reasons the JMPR does not recommend use of JMPR Evaluationsas the sole basis for safety assessment for national registrations.
If the evaluations are used for registration purposes, authorities should usedocumentation provided by manufacturers in accordance with national laws relating tothe submission and use of unpublished proprietary data to ensure that the JMPRevaluations are of pesticides manufactured by the same routes, of comparable purity andwith similar impurities to the pesticides that are being registered.
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7.2 Residue studies and recommended MRLs
The information relating to pesticide residues (e.g. results of supervised trials,metabolism, animal transfer, processing studies) can be used more generally than thesafety assessment of pesticides.
The comparability of the trial conditions discussed in detail in chapters 5 and 6should be assessed for deciding on the applicability of JMPR conclusions andrecommendations for the particular national use conditions.
Codex MRLs are meant to be used primarily to enforce and control compliancewith nationally authorised uses of pesticides on commodities moving in internationaltrade. The applicability of Codex MRLs for national use depends on the relation of GAPon which the maximum residue level estimates were based to the national GAP . Inmaking decisions on comparability of national use conditions to the trial conditionsdescribed in the monographs, the results of a few supervised trials carried out undertypical growing conditions of the country can be of great value.
In accordance with the principles of FAO International Code of Conduct on theDistribution and Use of Pesticides, governments “should promote the use of safe, efficientand cost effective application methods” in order to reduce the exposure of consumersand the environment resulting from the use of pesticides. When the national useconditions lead to substantially lower residues than the Codex MRL, the establishment oflower national MRLs may be considered for enforcing domestic uses since higher MRLswould encourage unauthorised use of the pesticide, which is against the principle ofGAP. However, for imported commodities the national authorities have an obligation toaccept higher Codex MRLs which afford an acceptable level of consumer protection, inaccordance with the provisions laid down in the Sanitary and Phytosanitary (SPS)agreement of the Uruguay Round of GATT.
7.3. Interpretation of residue analytical results in comparison with MRLs
A question frequently asked is whether the Codex MRLs, which are based on the limitsrecommended by the JMPR, should be considered either as strict limits or with theallowance of a further margin when considering the analysis of samples for enforcementpurposes.
By definition an MRL is a limit not to be exceeded. The burden of proof is on themonitoring authority to establish, with a high degree of assurance, whether the residue inthe lot being examined exceeds the MRL in order to make any regulatory actions.
The uncertainty of the analytical results (SR) deriving from the random variation
of the consecutive procedures comprises the uncertainties of sampling (SS), sample
preparation (SSp) and analysis (SA).
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(SR) = √[(SS)2 + (SSp)2 + (SA)2]
Since the average residue is the same the equation can be written as:
(CVR) = √ [(CVS)2 + (CVSp)2 + (CVA)2]
The uncertainty of the final analytical result (CVR) cannot be smaller than that of
any step of its measurement.The experiments show that, on average, the expectable minimum coefficient of
variation of residue results of supervised trials is around 0.3-0.4. In this estimate thevariation of replicate analyses accounted for is only 10% (Ambrus, 1996b).
However, much larger variations of analytical results are encountered in practice.A summary of answers to the question “What are considered acceptable values forreproducibility (deviations between laboratories)?”, sent out by the Working Group onMethods of Analysis of CCPR in 1987, produced the information summarised in Table7.3.1.
Table 7.3.1. Reproducibility of representative residue methods at different residuelevels.
Concentration, mg/kg Coefficient of variation, %
Mean Range
0.010.11
774522
20-20010-100
5-50
The figures in Table 7.3.1 are typical of the range of errors routinely encountered(using accepted analytical methods) in analyses for pesticide residues at theconcentrations indicated. In view of the variability inherent in an analytical method, adecision is needed on which analytical results are required to be sure that the residueconcentration in the sampled product exceeds the MRL.
Furthermore, international collaborative studies revealed that, in the comparison ofan analytical result with the MRL, accuracy (influenced by mainly systematic errors) ismore important than precision.
In order to obtain reliable results, the laboratories performing regulatoryenforcement analysis are encouraged to:
• establish internal quality control measures which enable them to assess thewithin laboratory variation of results;
• participate in international sample check programmes to assess the accuracyof their analysis;
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• pay attention to information on storage stability of residues and thedefinition of residues;
• strictly adhere to Codex guidelines for preparing the portion of commodityfor analysis;
• validate the sampling procedures used for obtaining samples, and ensureproper training of sampling officers.
The same precautions should be applied in performing supervised trials orselective surveys to provide data for estimating maximum residue levels.
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8. REFERENCES
The following documents were referred to or used in the preparation of the FAO Manual:
Ambrus Á. 1996a. Estimation of Uncertainty of Sampling for Analysis of PesticidesResidues. J. Environ. Sci. Health. B31. 435-442
Ambrus Á, Solymosné M.E. and Korsós I. 1996. Estimation of Uncertainty of SamplePreparation for the Analysis of Pesticide Residues. J. Environ. Sci. Health. B31. No.3. 443-450
EPA. 1996. EPA Residue Chemistry Test Guidelines OPPTS 860.1300, Nature of theResidue - Plants, Livestock. EPA 712-C-96-172.
EPA. 1996. EPA Residue Chemistry Test Guidelines OPPTS 860.1520, ProcessedFood/Feed. EPA 712-C-96-184.
FAO. 1989. Pesticide Residues in Food 1989 - Report. FAO Plant Production andProtection Paper No. 99. FAO, Rome.
FAO. 1990. Pesticide Residues in Food 1990 - Report. FAO Plant Production andProtection Paper No. 102. FAO, Rome.
FAO. 1990. International Code of Conduct on the Distribution and Use of Pesticides.FAO, Rome.
FAO. 1991. Pesticide Residues in Food 1991 - Report. FAO Plant Production andProtection Paper No. 111. FAO, Rome.
FAO. 1992. Pesticide Residues in Food 1992 - Report. FAO Plant Production andProtection Paper No. 116. FAO, Rome.
FAO. 1993. Pesticide Residues in Food 1993 - Report. FAO Plant Production andProtection Paper No. 122. FAO, Rome.
FAO. 1994. Pesticide Residues in Food 1994 - Report. FAO Plant Production andProtection Paper No. 127. FAO, Rome.
FAO. 1995. Pesticide Residues in Food 1995 - Report. FAO Plant Production andProtection Paper No. 128. FAO, Rome.
FAO. 1995. Manual on the development and use of FAO specifications for plantprotection products. 4th edition. FAO Plant Production and Protection Paper No.128. FAO, Rome.
FAO. 1996. Pesticide Residues in Food 1996 - Report. FAO Plant Production andProtection Paper (in press). FAO, Rome.
FAO/WHO. 1993. Codex Classification of Foods and Animal Feeds in CodexAlimentarius, 2nd ed., Volume 2. Pesticide Residues, Section 2. Joint FAO/WHOFood Standard
Programme. FAO, Rome.FAO/WHO. 1993. Portion of Commodities to which Codex MRLs apply in Codex
Alimentarius, 2nd ed., Volume 2. Pesticide Residues, Section 4.1. JointFAO/WHO Food Standard Programme. FAO Rome.
FAO/WHO. 1995. Codex Alimentarius Commission Procedural Manual, 9th ed. JointFAO/WHO Food Standard Programme. FAO, Rome.
FAO/WHO. 1995. Recommendations for the revision of the guidelines for predictingdietary intake of pesticide residues, Report of FAO/WHO Consultation,WHO/FNU/FOS/95.11.WHO, Geneva.
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FAO/WHO. 1997. Codex Alimentarius, 2nd ed., Volume 2A. Pesticide Residues. JointFAO/WHO Food Standard Programme, FAO, Rome.
Hamilton, D. J. et al. 1997. Optimum use of available residue data in the estimation ofdietary intake of pesticides. Pure and Applied Chemistry, Vol. (in press).
IPCS. 1996. Guidelines for the preparation of toxicological working papers for the CoreAssessment Group of the Joint Meeting on Pesticide Residues. IPCS/96.32,Geneva.
IPCS. 1996. Procedural guidelines for the preparation and review of working papers forthe Core Assessment Group of the Joint Meeting on Pesticide Residues.IPCS/96.33, Geneva.
ISO. 1993. Alphabetical List of Entities and Codes in English (ISO 3166:1993).IUPAC Commission on Agrochemicals and the Environment. 1996. Pure & Appl. Chem.,
Vol. 68, No. 5, pp. 1167-1193.OECD. OECD GLP Guidelines3:
Number 1 The OECD Principles of Good Laboratory Practice. Environmentmonograph No. 45, Paris (1992).
Number 4 GLP Consensus Document, Quality Assurance and GLP. Environmentmonograph No. 48, Paris (1992).
Number 6 GLP Consensus Document. The Application of the GLP Principles toField Studies, Environment monograph No. 50, Paris (1992).
Number 8 GLP Consensus Document. The Role and Responsibilities of the StudyDirector in GLP Studies, Environment monograph No. 74, Paris (1993).
WHO. 1989. Guidelines for predicting dietary intake of pesticide residues. GEMS/FoodWHO, Geneva.
WHO. 1995. Recommendations for the revision of the guidelines for predicting dietaryintake of pesticide residues. Report of the FAO/WHO Consultation,(WHO/FNU/FOS/95.11) Geneva.
3 The OECD GLP Guidelines are currently under revision. The publication of revised guidelines is expected in
1997.
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Appendix I
ABBREVIATIONS USED IN THE TEXT
ADI Acceptable Daily Intakeai active ingredientARfD Acute Reference Dosebw body weightCA Chemical AbstractsCAS Chemical Abstracts ServiceCAC Codex Alimentarius CommissionCCN Codex commodity numberCCPR Codex Committee on Pesticide ResiduesCIPAC Collaborative International Pesticides Analytical CouncilCXL Official Codex MRLEC European CommunityEDI Estimated Daily IntakeEMDI Estimated Maximum Daily IntakeERL Extraneous Residue LimitEMRL Extraneous Maximum Residue LimitFAO Food and Agriculture Organization of the United NationsGAP Good Agricultural PracticeGCPF Global Crop Protection FederationGIFAP Groupement International des Associations Nationales de Fabricants de
Produits Agrochimiques (International Group of National Associations ofManufacturers of Agrochemical Products), see GCPF
IEDI International Estimated Daily IntakeIUPAC International Union of Pure and Applied ChemistryISO International Standard OrganizationJMPR Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food
and the Environment and the WHO Expert Group on Pesticide ResiduesLOD limit of determinationMRL Maximum Residue LimitNEDI National Estimated Daily IntakePHI Pre-harvest intervalRAC Raw agricultural commoditySPS WTO Agreement on the Application of Sanitary and Phytosanitary
MeasuresSTMR Supervised Trials Median ResidueSTMR-P Supervised Trials Median Residue - processed commodityTMDI Theoretical Maximum Daily IntakeTMRLULV
Temporary Maximum Residue LimitUltra Low Volume
US EPA United States Environmental Protection AgencyWHO World Health Organization of the United NationsWTO World Trade Organization
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Appendix II
GLOSSARY OF TERMS
At the very early meetings some definitions were adopted by JMPR. A glossary ofdefinitions accepted by successive JMPR Meetings was added as Appendix IV to thereport of the 1969 Meeting (FAO/WHO Report, 1970a). Additions and ammendments tothe definitions have since been made at subsequent meetings. Below are the presentdefinitions used by the JMPR and CAC with the explanatory notes added to thedefinitions. The reader is referred to the IUPAC recommended Glossary of Terms relatingto Pesticides (IUPAC, 1996) for the definition of relevant terms not given in theseGuidelines.
Acceptable Daily Intake (ADI) (Codex Alimentarius, Vol. 2A)of a chemical is the daily intake which, during an entire lifetime, appears to bewithout appreciable risk to the health of the consumer on the basis of all theknown facts at the time of the evaluation of the chemical by the Joint FAO/WHOMeeting on Pesticide Residues. It is expressed in milligrams of the chemical perkilogram of body weight.(Note: For additional information on ADIs relative to pesticide residues, refer to theReport of the 1975 Joint FAO/WHO Meeting on Pesticide Residues, FAO PlantProduction and Protection Series No.1 or WHO Technical Report Series No. 592.)
Critical supporting studiesare metabolism, animal transfer, processing, analytical methods and freezerstorage stability studies.
Definition of residues (for compliance with MRLs)is that combination of the pesticide and/or its metabolites, derivatives and relatedcompounds to which the MRL applies. (Ref. JMPR Report 1995, 2.8.1.)
Explanatory note: The residue definition for compliance with MRLs depends on theresults of metabolism and toxicology studies, supervised residue trials, analyticalmethods and its general suitability for monitoring compliance with GAP.
Definition of residues (for estimation of dietary intake)is that combination of the pesticide and/or its metabolites, impurities anddegradation products to which the STMR applies.
Explanatory note: The residue definition for estimation of dietary intake depends onthe results of metabolism and toxicology studies and its general suitability forestimating dietary intake of the residue for comparison with the ADI.
Derived edible products (Ref. JMPR Report 1979, Annex 3)"For the purposes of Codex Alimentarius, the term "derived edible products"means food or edible substances isolated from primary food commodities or
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raw agricultural commodities not intended for human consumption as such,using physical, biological or chemical processes."
Desirable ( JMPR Report 1986, 2.5)"Information desired for the continued evaluation of the compound."
Extraneous Maximum Residue Limit (EMRL) (Codex Alimentarius Vol. 2A). refers to a pesticide residue or a contaminant arising from environmentalsources (including former agricultural uses) other than the use of the pesticideor contaminant substance directly or indirectly on the commodity. It is themaximum concentration of a pesticide residue that is recommended by theCodex Alimentarius Commission to be legally permitted or recognised asacceptable in or on a food, agricultural commodity or animal feed. Theconcentration is expressed in milligrams of pesticide residue or contaminant perkilogram of the commodity.
Explanatory Notes:The term EMRL is synonymous with “Extraneous Residue Limit” (ERL) which isused by the JMPR.
Residues in Food of animal origin arising from residues in animal feed derived fromactivities that are controllable by farming practices are covered by "maximumresidue limits". The term "practical residue limit", which has led to much confusion,has been abandoned.
The definition of ERL replaced the expressions "practical residue limit" and"unintentional residue", in existence since the 1967 JMPR.
Good Agricultural Practice (CAC, 1995)"Good Agricultural Practice in the use of Pesticides (GAP ) includes thenationally authorised safe uses of pesticides under actual conditions necessaryfor effective pest control. It encompasses a range of levels of pesticideapplications up to the highest authorised use, applied in a manner which leaves aresidue which is the smallest amount practicable.
Authorised safe uses are determined at the national level and include nationallyregistered or recommended uses, which take into account public andoccupational health and environmental safety considerations.
Actual conditions include any stage in the production, storage, transport, dis-tribution of food commodities and animal feed."
Guideline Level (JMPR Report 1975, Annex 3)"A Guideline Level is the maximum concentration of a pesticide residue thatmight occur after the official recommended or authorized use of a pesticide for
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which no acceptable daily intake or temporary acceptable daily intake isestablished and that need not be exceeded if good practices are followed. It isexpressed in milligrams of the residue per kilogram of the food".
International Estimated Daily Intake (IEDI)The International Estimated Daily Intake (IEDI) is the estimate of long-termdietary intake of a pesticide residue based on WHO cultural diets, the STMR andfactors such as food-processing that can be used at the international level.
Limit of Determination (Codex Alimentarius, Vol. 2A)is the lowest concentration of a pesticide residue or contaminant that can beidentified and quantitatively measured in a specified food, agriculturalcommodity or animal feed with an acceptable degree of certainty by a regulatorymethod of analysis.
Maximum Residue Levelis estimated by the JMPR as the maximum concentration of residues (expressedas mg/kg) which may occur in a food or feed commodity following GoodAgricultural Practices. The estimated maximum residue level is considered bythe JMPR to be suitable for establishing Codex MRLs.
Maximum Residue Limit (MRL) (Codex Alimentarius Vol. 2A)is the maximum concentration of a pesticide residue (expressed as mg/kg),recommended by the Codex Alimentarius Commission to be legally permitted inor in food commodities and animal feeds. MRLs are based on GAP data andfoods derived from commodities that comply with the respective MRLs areintended to be toxicologically acceptable.
Codex MRLs, which are primarily intended to apply in international trade,are derived from estimations made by the JMPR following:
a) toxicological assessment of the pesticide and its residue; and
b) review of residue data from supervised trials and supervised uses includingthose reflecting national good agricultural practices. Data from supervisedtrials conducted at the highest nationally recommended, authorised orregistered uses are included in the review. In order to accommodatevariations in national pest control requirements, Codex MRLs take intoaccount the higher levels shown to arise in such supervised trials, whichare considered to represent effective pest control practices.
Consideration of the various dietary residue estimates and determinationsboth at the national and international level in comparison with the ADI, should indicatethat foods complying with Codex MRLs are safe for human consumption.
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Explanatory note: The Maximum Residue Limit applies to the product when firstoffered in commerce, unless otherwise indicated. For commodities enteringinternational trade the MRL is applicable at the point of entry into a country or assoon as practicable thereafter and, in any event, before processing.
Multi-ingredient manufactured food (JMPR Report 1979, Annex 3)"For the purposes of Codex Alimentarius, the term "multi-ingredientmanufactured food" means a "processed food" consisting of more than one majoringredient".
Pesticide (JMPR Report 1975, Annex 3)"A pesticide is any substance or mixture of substances intended for preventing orcontrolling any unwanted species of plants and animals and also includes anysubstances or mixture of substances intended for use as a plant-growth regulator,defoliant or dessicant".
Explanatory Note: The term "pesticide" includes any substance used for the controlof pests during the production, storage, transport, marketing or processing of foodfor man or animals or which may be administered to animals for control of insects orarachnids in or on their bodies. It does not apply to antibiotics or other chemicalsadministered to animals for other purposes, such as to stimulate their growth or tomodify their reproductive behaviour; nor does it apply to fertilizers.
Pesticide" (CAC, 1995) means any substance intended for preventing, destroying, attracting, repelling, or
controlling any pest including unwanted species of plants or animals during theproduction, storage, transport, distribution and processing of food, agriculturalcommodities or animal feeds, or which may be administered to animals for thecontrol of ectoparasites. The term includes substances intended for use as aplant-growth regulator, defoliant, desiccant, fruit-thinning agent, or sproutinginhibitor and substances applied to crops either before or after harvest to protectthe commodity from deterioration during storage and transport. The termnormally excludes fertilizers, plant and animal nutrients, food additives andanimal drugs.
Pesticide Residue ( JMPR Report 1975, Annex 3)"A pesticide residue is any substance or mixture of substances in food for manor animals resulting from the use of pesticide and includes any specifiedderivates, such as degradation and conversion products, metabolites, reactionproducts and impurities which are considered to be of toxicologicalsignificance."
Explanatory note. The term "pesticide residue" includes residues from unknownsources (i.e. background residues) as well as those from known uses of the chemicalin question.
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Adjuvants are not included in the definition of residues.
Pesticide Residue (CAC)means any specified substance in food, agricultural commodities or animal feedresulting from the use of a pesticide. The term includes any derivatives of apesticide, such as conversion products, metabolites, reaction products andimpurities considered to be of toxicological significance.
Primary Food Commodity (JMPR Report 1979, Annex 3)" For the purposes of the Codex Alimentarius, the term "Primary FoodCommodity" means the product in or nearly in its natural state intended forprocessing into food for sale to the consumer or as a food without further pro-cessing. It includes irradiated primary food commodities and products afterremoval of certain parts of the plant or parts of animal tissue".
Processed food - general definition (JMPR Report 1979, Annex 3)"For the purposes of the Codex Alimentarius, the term "processed food" meansthe product, resulting from the application of physical, chemical or biologicalprocesses to a "primary food commodity" intended for direct sale to theconsumer, for direct use as an ingredient in the manufacture of food or forfurther processing. "Primary food commodities" treated with ionizing radiation,washed, sorted or submitted to similar treatment are not considered to be"processed foods". ”
Provisional Tolerable Daily Intake (JMPR Report 1994, 2.3)“A value based on toxicological data. It represents tolerable human intake of aformer agricultural pesticide that may occur as a contaminant in food, drinkingwater and the environment”.
Explanatory note: The term “tolerable” rather than “acceptable” is used to signifypermissibility rather than acceptability of the intake of environmental contaminantsunavoidably associated with the consumption of otherwise wholesome food. Use ofthe term “provisional” expresses the fact that reliable data on the consequences ofhuman exposure to these pesticides are lacking and that the submission from anysource of relevant safety data is encouraged.
Regulatory Method of Analysis (JMPR Report 1975, Annex 3)"A regulatory method of analysis is a method suitable for the determination of apesticide residue in connexion with the enforcement of legislation".
Explanatory note: For this purpose, it is often necessary to identify the nature of theresidue as well as to determine its concentration. Subject to any expression ofrequirements in the particular legislation, the accuracy, the precision and limit ofdetermination of a regulatory method need to be sufficient only to demonstrateclearly whether or not a Maximum Residue Limit has been exceeded. Usually
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regulatory methods are not specified in pesticide residues legislation, and at anygiven time there may be a number of methods suitable for a particular purpose.
Required (JMPR Report 1986, 2.5)"Information required in order to estimate maximum residue levels or confirmtemporary estimates".
Explanatory note. Results of further work required should be made available notlater than the specified date, after which the compound will be re-evaluated. The re-evaluation may be carried out at an earlier Meeting if relevant information shouldbecome available. Each recommended TMRL will be directly related to an item ofrequired information (Ref. JMPR Report 1992, 2.8).
Secondary Food Commodity (Ref. JMPR Report 1979, Annex 3)“For the purposes of Codex Alimentarius, the term "Secondary FoodCommodity" means a "Primary Food Commodity" which has undergone simpleprocessing, such as removal of certain portions, drying, husking andcomminution, which do not basically alter the composition or identity of theproduct. Secondary food commodities may be processed further or may be usedas an ingredient in the manufacture of food or may be sold directly to theconsumer".
Single-ingredient manufactured food (JMPR Report 1979, Annex 3)"For the purposes of Codex Alimentarius, the term "single-ingredientmanufactured food" means a "processed food" which consists of one identifiablefood ingredient with or without packing medium or with or without minoringredients, such as flavouring agents, spices and condiments, and which isnormally pre-packaged and ready for consumption with or without cooking".
Supervised trials (for estimating mrls) (New definition)Scientific studies in which pesticides are applied to crops or animals accordingto specified conditions intended to reflect commercial practice after whichharvested crops or tissues of slaughtered animals are analysed for pesticideresidues. Usually specified conditions are those which approximate existing orproposed GAP .
Supervised Trials Median Residue (STMR)The supervised trials median residue (STMR) is the expected residue level(expressed as mg/kg) in the edible portion of a food commodity when a pesticidehas been used according to maximum GAP conditions. The STMR is estimated asthe median of the residue values (one from each trial) from supervised trialsconducted according to maximum GAP conditions.
Temporary MRL (TMRL) or Temporary EMRL (TEMRL) (Codex Alimentarius Vol. 2A)is an MRL or EMRL established for a specified, limited period and isrecommended under either of the following conditions:
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1. Where a temporary acceptable daily intake has been estimated by the JointFAO/WHO Meeting on Pesticide residues for the pesticide orcontaminant of concern; or
2. Where, although an acceptable daily intake has been estimated, the goodagricultural practice is not sufficiently known or residue data areinadequate for proposing an MRL or ERL by the Joint FAO/WHO Meetingon Pesticide Residues.
(Note: TMRLs and TERLs are not to be advanced further than Step 7 of the CodexProcedure)
The 1992 JMPR gave the following definition (Report, section 2.8):“A temporary maximum residue limit is a maximum residue limit for a specified,limited period, which is clearly related to required information.”
Comments:The "Temporary maximum residue limit" is a successor of the "temporarytolerance" introduced by the 1966 JMPR, which was changed to “temporarymaximum residue limit” in 1975.At the 1988 JMPR the decision was taken not to establish Temporary AceptableDaily Intakes any longer for new and periodic review compounds.
According to the Report of 1992 JMPR, there is still a possibility that TMRLsmay be recommended when the information lacking on some residue aspects is unlikelyto affect the validity of an estimated maximum residue level and would be availableshortly. Each recommended TMRL will be directly related to an item of requiredinformation.
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Appendix III
CIPAC CODES FOR PESTICIDE FORMULATIONS
AB Grain bait KL Combi-pack liquid/liquid*AE Aerosol dispenser KN Cold fogging concentrateAL Other liquids to be applied undiluted KP Combi-pack solid/solid*BB Block bait LA LacquerBR Briquette LS Solution for seed treatmentCB Bait concentrate MG MicrogranuleCG Encapsulated granule OF Oil miscible flowable concentrate (oil
miscible suspension)CS Capsule suspension OL Oil miscible liquidDC Dispersible concentrate OP Oil dispersible powderDP Dustable powder PA PasteDS Powder for dry seed treatment PB Plate baitEC Emulsifiable concentrate PC Gel concentrate or paste concentrateED Electrochargeable liquid PO Pour-onEO Emulsion, water in oil PR Plant rodletES Emulsion for seed treatment PS Seed coated with a pesticideEW Emulsion, oil in water RB Bait (ready to use)FD Smoke tin SA Spot-onFG Fine granule SB Scrap baitFK Smoke candle SC Suspension concentrate(= flowable
concentrate)FP Smoke cartridge SE Suspo-emulsionFR Smoke rodlet SG Water soluble granuleFS Flowable concentrate for seedtreatment
SL Soluble concentrate
FT Smoke tablet SO Spreading oilFU Smoke generator SP Water soluble powderFW Smoke pellet SS Water soluble powder for seed
treatmentGA Gas SU Ultra-low volume (ULV) suspensionGB Granular bait TB TabletGE Gas generating product TC Technical materialGG Macrogranule TK Technical concentrateGL Macrogranule TP Tracking powderGP Flo-dust UL Ultra-low volume (ULV) liquidGR Granule VP Vapour releasing productGS Grease WG Water dispersible granuleGW Water soluble gel WP Wettable powderHN Hot fogging concentrate WS Water dispersible powder for slurry
treatmentKK Combi-pack solid/liquid* XX Others
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* Special two-letter codes for twin-packs.
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Appendix IV
MRL PERIODIC REVIEW PROCEDURE BY CCPR(ALINORM 97/24 APPENDIX III)
CODEX COMMITTEE ON PESTICIDE RESIDUESMRL PERIODIC REVIEW PROCEDURE4
The periodic Review Procedure consists of two distinct phases as described below:
PHASE I
IDENTIFY PERIODIC REVIEW CHEMICALS AND SOLICIT DATA COMMITMENTS(Year 1, CCPR Meeting)
1. Identify Candidate Chemicals for Re-evaluation
On an annual basis the CCPR (Working Group on Priorities) lists chemicalsmeeting the following criteria:
- pesticide chemicals for which MRLs were first estimated more than 10 yearsago; or
- pesticide chemicals for which a periodic review was conducted more than 10years ago.
Tentative lists for several years may be prepared when feasible.
2. Notify Data Owners or Other Parties of Candidate List
Governments and international organizations represented at the annual CCPRMeeting expeditiously notify current data owners (or other interested parties) ofthe candidate list for periodic reviews, and when available, tentative lists for thefollowing years. A copy of the most recent procedure for periodic review is alsoincluded.
3. Invite Commitment to Support Continued (or New) Codex Maximum ResidueLimits (CXLs)
With their notification to data owners (or other interested parties) on the candidacyof chemicals for periodic review, governments and international organizationsinquire of these parties their willingness to provide data for that review and also toadvise them of the implications if they choose not to.
The invitation for a commitment will request a written response within six monthsto be provided to:
4 At the time of the preparation of the Guidelines this text was under submission to the Codex AlimentariusCommission for endorsement at its 22nd session in 1997.
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- Chairman, CCPR- Chairman, Priorities Working Group- JMPR Secretariats- the requester (government or international organization representative)
(Names, titles and addresses will be provided)
The invitation will request that the following information be provided in theresponse:
a. A list of all commodities for which interested parties are willing to supportCXLs.
b. A brief summary of all current Good Agricultural Practice (GAP ) which theyare willing to provide and which is pertinent to residue data they are willing toprovide (e.g. commodities and countries for which detailed GAP summariesand representative labels can be provided).
c. A lists of all chemistry (residue, metabolism, animal transfer, processing,analytical sample storage stability, analytical methods etc.) and toxicologystudies and other data that they are willing to provide (regardless of whetherpreviously provided) and the complete data package submissions to theJMPR. Comments on the status of registrations for the chemicals at thenational level are encouraged. Data for which a submission is committedshould be identified in the response by study or report title and number,author and date.
4. Repeat the Notification and Invitation
By means of a Codex Circular Letter to accompany the report of the Meeting theSecretariat will repeat the notification and request. On receipt of the request by theCircular Letter, governments and international organizations will immediatelyrepeat their notification and invitation to identified interested parties who may nothave been represented at the CCPR (they would not have received the report of theMeeting or the accompanying Circular Letter). Interested parties need onlyrespond to one of the requests, but should copy addresses listed in item 3 above.
PHASE II
STATUS REPORT ON DATA COMMITMENTS AND CCPR FOLLOW-UP(Year 2, CCPR Meeting)
1. Status Report on Data Commitments - The Priorities Working Group will provide areport and room document to the CCPR on the status of commitments received toprovide data for each compound identified in year 1. This information will be usedto schedule JMPR reviews or to make other recommendations such as withdrawalof CXLs.
2. Response to Data Commitments
a. If there is no commitment to provide and identify or develop data to supportcurrent CXLs, the CXL(s) will be recommended by the CCPR for withdrawalby the next session of the Codex Commission.
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b. If a commitment is made to provide and identify or develop data to supportcurrent CXLs, the MRL(s) are scheduled for JMPR review. The JMPRreview will result in one of the following scenarios:
- Sufficient data are submitted to confirm the CXL and it remains in place.
- Sufficient data are submitted to support a new proposed MRL, it enters theprocess at Step 3 and the existing CXL is deleted automatically after no morethan 4 years.
If insufficient data have been submitted to support a new MRL or to confirmthe existing CXL, data submitters are so advised by written notification fromthe FAO Joint Secretary and/or by issuance of the JMPR Report.
On being advised of the data inadequacy, data submitters may by the nextCCPR Meeting, provide to the FAO and CCPR Secretaries a writtencommitment to generate and submit a complete dossier of required data forreview within 4 years. The CXL is maintained for no more than 4 yearsfollowing advice of data inadequacy (by direct notification or by issuance ofthe JMPR Report). The 4-year period may be extended by the CCPR only tothe extent necessary for the JMPR to schedule and complete review of theavailable new data.
The new data are scheduled for the second JMPR review and the first part ofthe PHASE II 2b procedure is repeated:
- Sufficient data are submitted to confirm the CXL and it remains inplace.
- Sufficient data are submitted to support a new proposed MRL and itenters the process at Step 3. The CXL is automatically deleted no morethan 4 years after the new proposal enters the process.
- Insufficient data are submitted to confirm the CXL or support aproposed MRL and the CCPR recommends deletion of the CXL.
c. If the committed data are not submitted, or if the data submitted for the initialperiodic review are insufficient and no commitment is made by the nextCCPR Meeting to generate new data, the CCPR recommends deletion of theCXL.
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SUMMARY OF PERIODIC REVIEW PROCEDURE FOR CODEX MRLs
PESTICIDE SELECTED FOR PERIODIC REVIEW
COMMITMENT FOR DATA SUBMISSION NO COMMITMENT FOR DATA SUBMISSION
CXL1 RECOMMENDED FOR DELETION BY CCPRJMPR EVALUATION AND PROPOSALS
SUFFICIENT DATA ARESUBMITTED TO CONFIRM CXL
1SUFFICIENT DATA ARE
SUBMITTED TO SUPPORT NEWMRL
INSUFFICIENT DATA ARESUBMITTED TO CONFIRM CXL
1 OR
SUPPORT MRL
CXL1 IS MAINTAINED - NEW MRL CIRCULATED AT STEP 3 (3(a))
- EXISTING CXL1 deleted after no morethan 4 years
COMMITMENT IS MADE BY THE TIMEOF THE NEXT CCPR TO PROVIDE DATA
NO COMMITMENT IS MADE TOPROVIDE DATA
CXL MAINTAINED FOR NO MORE THAN 4 YEARSFOLLOWING AVAILABILITY OF JMPR REPORT OR
WRITTEN NOTIFICATION OF RESULTS
CXL1 RECOMMENDED FORDELETION BY CCPR
2ND JMPR EVALUATION AND PROPOSALS
SUFFICIENT DATA ARESUBMITTED TO CONFIRM CXL1
SUFFICIENT DATA ARESUBMITTED TO SUPPORT AN MRL
INSUFFICIENT DATA ARESUBMITTED TO CONFIRM CXL OR
TO SUPPORT MRL
CXL1 IS RECOMMENDED FORDELETION BY CCPR
CXL1 IS MAINTAINED - NEW MRL CIRCULATED AT
STEP 3 (3(a))
1 Codex MRL adopted by the Codex Alimentarius Commission. The Codex AlimentariusCommission may decide to delete certain Codex MRLs based on the recommendations made to it by theCodex Committee on Pesticide Residues.
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Appendix V
RECOMMENDED SAMPLING METHOD FOR SUPERVISED FIELDTRIALS5
1. General Recommendations
The best information about the residue behaviour of the pesticide under studywould be obtained by the analysis of the entire yield of a plot. Since this is notpracticable, representative samples have to be taken. Careful attention to thedetails of sampling is essential if worthwhile samples are to be obtained. Validanalytical results can only be obtained if the samples have been properly taken,despatched and stored before analysis.
In selecting sampling points and/or the sampling method, all factors thatcontrol the residue distribution over the entire experimental plot must beconsidered. The best approach for any given plot can only be determined by asufficiently trained person who is capable of recognising the importance andusefulness of the residue data sought, and who can interpret the results.
The samples must be representative to enable the analytical result to beapplied to the entire experimental unit. The greater the number of plants sampledin a field plot, the more representative the sample will be. However, economicsand the practical problems involved in handling large samples affect the magnitudeof the sampling programme. The size of sample suggested is the minimum thatexperience has shown is needed to give a representative, valid sample. The sizesare not usually dictated by the analytical method, which can often determineminute amounts of pesticides in small amounts of sample.
1.1 Method of Sampling
Generally, the selection of the portions that make up the field sample should bemade depending on the circumstances:
• randomly, e.g. by the use of random numbers• systematically, .e.g. in the case of field crops on a diagonal ("X"or an "S” course)• selectively from predetermined sampling-points, e.g. in the case of tree fruits,take both exposed samples and those covered by foliage so that each fruit has anequal chance of being taken.
Points to be borne in mind are:
5 This procedure is extracted with some modifications form FAO Guidelines on Producing Pesticide Residues Data fromSupervised Trials, FAO Rome 1990.
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• Avoid taking samples at the beginning or at the extreme end of plots (start andfinish of spraying).
• Take and bag the required weight or number of samples in the field and do notsubsample until the samples are in a clean field laboratory or in the analyticallaboratory.
• Sample all parts of the crop that can be consumed by humans or livestock.
• Sample the parts of the crop that normally constitute the commercialcommodity as described in Appendix VI.
• Where appropriate, consider commercial harvesting practice which reflectsnormal "Good Agricultural Practice" (see also section 2).
1.2 Replication
In certain cases where there is likely to be considerable within-plot variation, suchas orchard and glasshouse trials, three sample replicates per plot may be taken ator near harvest.6 Sample integrity should be maintained throughout the procedure.
1.3 Sample Handling
• Take care not to remove surface residues during handling, packing orpreparation.
• Avoid any damage to or deterioration of the sample which might affect residuelevels.
• To provide a representative sample of the raw commodity, adhering soil mayhave to be removed from some crops, such as root crops. This may be done bybrushing and, if necessary, gentle rinsing with cold running water (see also4.3.2.1).
• Sample control plots before treated plots (see also 2 and 3).
2. Contamination
It is vital to avoid any contamination with the pesticide under study or with otherchemicals during sampling, transportation or subsequent operations. Specialattention should, therefore, be paid to the following:
• Ensure that sampling tools and bags are clean. To avoid contamination use newbags and containers of suitable size and adequate strength. The bags orcontainers should be made of materials which will not interfere with theanalysis.
6 The Study Plan should prescribe when replicate samples are needed. Replicate samples should be clearly indicated in thesampling and analytical reports.
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• Avoid contamination of the sample by hands and clothes which may have been incontact with pesticides.
• Do not allow the samples to come into contact with containers or equipment(including vehicles) that have been used for transporting or storing pesticides.
• Avoid sampling at the plot borders because the residue deposit may not berepresentative 7.
• Take special care to avoid contamination when commercial mechanicalharvesting practices are used (see also 4.3.3.1, 4.3.4 and 4.3.5).
• Avoid cross-contamination of crop and soil samples.
• Sampling should proceed from the control to the lowest treatment and so on tothe highest treatment.
3. Control Samples
Control samples are in every way as important as samples from test plots. Thequality of control samples should be similar to that of the test samples, e.g.maturity of fruit, type of foliage, etc.
Always take control samples. In decline studies of up to 14 days’ duration,control samples from the start and from the end of the study may suffice (see also4.1).
4. Sampling in Decline Studies and at Normal Harvest Time
Representative and valid sampling protocols might be different for decline studiesand residue trials at normal harvest time.
4.1 Sampling in Decline Studies
The first sampling may take place on the day of application. These samples have tobe taken immediately after application or, in the case of spray application,immediately after the spray has dried (approx. 2 hours).
• Take great care to avoid contamination.
• Take samples so as to be representative of the average size or weight of crop onthe plot.
7 The possibility of spray drift or overlap, especially where the plot is small and particularly when various pesticides anddosages are applied to adjacent areas should be considered and avoided when the experimental plots are marked.
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4.2 Sampling at Normal Harvest Time
• Take samples so as to be representative of typical harvesting practice.
• Avoid taking diseased or undersized crop parts or commodities at a stage whenthey would not normally be harvested.
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4.3 Detailed Sampling Procedures
The following recommendations refer to the sampling of mature crops at normalharvest time, unless otherwise stated. The classification of the crops is containedin Section 2 of Codex Alimentarius Volume 2A.
4.3.1 Fruits and Tree Nuts
• Circle each tree or bush and select fruit from all segments of the tree or plant,high and low, exposed and protected by foliage. For small fruits grown in a row,select fruit from both sides, but not within 1 metre of the end of the row.
• Select the quantity of the fruit according to its density on the tree or plant, i.e.take more from the heavily-laden parts.
• Take both large and small fruits where appropriate, but not so small or damagedthat they could not be sold (except when taking immature samples for a residuedecline study).
• Take samples of fruit juices, cider and wine in a manner reflecting commonpractice.
Table V.1 Sampling of fruits
Commodity Codex Code No. Quantity, method of collectionCitrus fruits e.g. orange, lemon, mandarin,pomelo, grapefruit, clementine, tangelo,tangerine
Group 001
Pome fruits e.g. apples, pears, quinces,medlars
Group 002 12 fruits from several places on 4individual trees.
Large stone fruit e.g. apricots, nectarines,peaches, plums
Group 003 (If this produces a sample weight of lessthan 2 kg, more fruit should be taken toyield a 2 kg sample)
Miscellaneous fruit e.g. avocados, guavas,mangoes, papayas, pomegranates,persimmons, kiwifruit, litchi
Group 006
Small stone fruit e.g. cherries Group 003 1 kg from several places on 4 trees
Grapes FB 0269 12 bunches, or parts of 12 bunches, fromseparate vines to give at least 1 kg
Currants, raspberries and other small berries Group 004 0.5 kg from 12 separate areas or bushes
Strawberries,
Gooseberries
FB 0275, 0276 FB0268
1 kg from 12 separate areas or bushes
Miscellaneous small fruits e.g. olives,dates, figs
Group 005 1 kg from several places on 4 trees
Pineapples Fl 0353 12 fruits
Bananas Fl 0327 24 fruits. Take two fingers each from top,middle and lowest hand of four harvestablebunches
Tree nuts e.g. walnuts, chestnuts,
almonds
Group 022 1 kg
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Coconut TN 0655 12 nuts
Fruit juices , wine, cider Group 070 1 litre
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4.3.2 Vegetables
4.3.2.1 Bulb vegetables, root vegetables, tuber vegetables:
• Take samples from all over the plot, excluding 1 metre at the edges of the plotand the ends of the rows. The number of sampling points depends on the samplesize of the crop (see below).
• To provide a representative sample of the raw commodity, adhering soil mayhave to be removed. This may be done by brushing and, if necessary, gentlerinsing with cold running water.
• Trim off tops according to local agricultural practice. Details of any trimmingshould be recorded. Where the tops are not used as animal feed (carrots,potatoes) they should be discarded; otherwise (e.g. turnips, beets) they shouldbe bagged separately.
Table V.2 Sampling of bulb, root and tuber vegetables
Commodity Codex Code No. Quantity, method of collectionFodder beets,
Sugar beets
AM 1051
VR 0596
12 plants
Potatoes VR 0589 12 tubers (the sample should weigh at least2 kg - where necessary, take a largernumber to produce a 2 kg sample)
Other root crops e.g. carrots, red beet,Jerusalem artichoke, sweet potato, celeriac,turnip, swede, parsnip, horseradish, salsify,chicory, radish, scorzonera
Group 016 12 roots (the sample should weigh at least2 kg - where necessary, take a largernumber to produce a 2 kg sample)
Leeks,
Bulb onions
VA 0384
VA 0385
12 plants
Spring onions VA 0389 24 plants (the sample should weigh at least2 kg - where necessary, take a largernumber to produce a 2 kg sample)
Garlic,
Shallots
VA 0381
VA 0388
12 bulbs from 12 plants.(the sampleshould weigh at least 2 kg - wherenecessary, take a larger number to producea 2 kg sample)
4.3.2.2 Brassica vegetables, leafy vegetables, stalk and stem vegetables, legumevegetables and fruiting vegetables:
• Take the sample from all parts of the plot, leaving 1 metre at the edges and endsof rows. The number of sampling points depends on the sample size of the crop(see below).
• Sample items of crops such as peas or beans protected from the spray by foliageand also from parts exposed to the spray.
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• To provide a representative sample of the raw commodity, adhering soil mayhave to be removed. This may be done by brushing and, if necessary, gentlerinsing with cold running water.
• Do not trim except for the removal of obviously decomposed or witheredleaves. Details of any trimming should be recorded.
The quantities to be taken are shown in Table V.3.
4.3.3 Grasses
4.3.3.1 Cereals
• If the plot is small, cut the whole yield.
• If the plot is large but mechanical harvesting is not carried out, cut not less thantwelve short lengths of row chosen from all over the plot. Cut stalks 15 cmabove the ground and remove the grain from the straw.
• Care should be taken to avoid contamination when mechanical methods are usedto separate the parts of the crop. The operation is best carried out in thelaboratory.
• If the plots are harvested mechanically, take not less than twelve grab samples ofgrain and/or straw from the harvester at uniform intervals over the plot.
• Do not sample within 1 metre of the edges of the plot.
4.3.3.2 Grasses, forage and animal feed:
• Cut with shears at normal harvest height (usually 5 cm above the ground) thevegetation from not less than twelve areas uniformly spaced over the entire plot,leaving 1 metre at the edges of the plot.
• Record height of cutting and avoid soil contamination.
• Crops which are harvested mechanically can be sampled from the harvester as itproceeds through the crop.
The quantities to be taken are shown in Table V.5.
4.3.3.3 Sugar cane (GS 0659)Select whole canes from 12 areas of the plot and take short (e.g. 20 cm) sectionsfrom all parts of the length of the canes. Care is necessary owing to the rapidchanges which normally occur in cane juices. If required, 1 litre samples of juiceshould be taken and frozen immediately and then shipped in cans.
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Table V.3 Sampling of other vegetables
Commodity CodexCode No.
Quantity, method of collection
Large Brassica crops e.g. cabbage,cauliflower, kohlrabi
Group 010 12 plants
Broccoli VB 0400 1 kg from 12 plants
Brussels sprouts VB 0402 1 kg from 12 plants. Buttons to be taken from at leasttwo levels on each plant.
Cucumbers VC 0424 12 fruits from 12 separate plants
Gherkins, courgettes, squash Group p 011 12 fruits from 12 plants (the sample should weigh atleast 2 kg - where necessary take a larger number offruit to produce a 2 kg sample)
Melons, gourds, pumpkins, watermelons8 Group 011 12 fruits from 12 separate plants
Egg plants (aubergines) VO 0440 12 fruits from 12 separate plants
Sweet corn VO 0447 12 ears (the sample should weigh at least 2 kg - wherenecessary take a larger number of items to produce a 2kg sample.)
Mushrooms VO 0450 12 items (the sample should weigh at least 0.5 kg -where necessary take a larger number of items toproduce a 0.5 kg sample)
Tomatoes,
Peppers
VO 0448
VO 0051
24 fruits from small-fruiting varieties, 12 from largefruiting varieties. From 12 plants in all cases. (Thesample should weigh a minimum of 2 kg - wherenecessary take a larger number of items to produce a 2kg sample.)
Endivea VL 0476 12 plants
Lettucea VL 0482, VL0483
12 plants
Spinacha,
Chicory leavesa
VL 0502
VL 0469
1 kg from 12 plants
Kale VL 0480 2 kg from 12 plants sampled from two levels on theplant
Small-leaf salad crops e.g. cress, dandelion,corn salad
Group 013 0.5 kg from 12 plants (or sites
in plot)
Peas, Phaseolus beans e.g. French, kidney,runner
Group 014 1 kg (fresh green or dry seed as appropriate)
Pulses e.g. dried broad beans, field beans,lentils, soya beans
Group 015 1 kg
Celery VS 0624 12 plants
Asparagus,
Rhubarb
VS 0621
VS 0627
12 sticks from 12 separate plants.(the sample shouldweigh a minimum of 2 kg where necessary take a largernumber of sticks to produce a 2 kg sample)
Globe artichoke VS 0620 12 heads
Fodder crops Groups 050,
051, 052
2 kg from 12 separate areas of plot. (Crops harvestedmechanically can be sampled from the harvester as itproceeds through the crop.)
Oilseed e.g. rape seed, mustard seed, poppy Group 023
8 In case of large crops, a sample consisting of 12 units could be 50-100 kg or more. In such cases the samplesize may be reduced to 5 units which conforms with the sample size recommended by the CCPR for enforcement.
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seed
Note: (a) also at immature stages during decline studies
Table V.4 Sampling of cereals
Commodity Codex Code No. Quantity, method of collectionCereal grains e.g. wheat, barley, oats, rye,triticale and other small grain cereals; maize (offthe cob), rice, sorghum
Group 020 1 kg
Straw of the above crops Group 051 0.5 kg
Maize straw, fodder and forage
(mature plants excluding cobs)
AF 0645 (forage)
AS 0645 (fodder)
12 plants. (Cut each stem into three equallengths (with leaves attached). Take top portionfrom stems 1 to 4, middle portion from stems 5to 8 and bottom portion from stems 9 to 12,thus ensuring that parts of all 12 stems areincluded in the sample.)
Green or silage maize Group 051 12 plants. (Cut each stem and subsample as inprevious item, retaining any cobs present on theappropriate portions of stem.)
Maize cobs Group 051 12 ears. (The sample should weigh at least 2 kg -where necessary, take a larger number of ears toproduce a 2 kg sample.)
Table V.5 Sampling of forage crops and animal feed
Commodity Codex Code No. Quantity, method of collectionGreen forage/silage crops of alfalfa, clover, peaand bean forage, vetch, sainfoin, lotus, soyabean fodder and forage, rye forage, foddercereals, sorghum forage
Group 050, 051 1 kg
Dry hay of the above crops Group 050, 051 0.5 kg
4.3.4 Seeds
Use essentially the same technique as for cereals, taking samples of mature seedfrom at least twelve parts of the plot. Where the sample is harvested by hand, seedshould normally be sent to the laboratory in the pod. Where mechanical harvestingis used, only the seed should normally be supplied.
Cotton seed (Codex Code No. SO 0691):• Pick the cotton at the normal stage of harvesting. Take 1 kg, with or withoutfibre.
Peanuts (Codex Code No. SO 0697):• Collect at the normal stage of harvesting. Take 1 kg.
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Sesame seed, rape seed (Codex Code Nos. SO 0700, SO 0495):• Collect the pods when they have reached the stage of maturity at which they are
normally harvested. Take 0.5 kg.
Sunflower seed, safflower seed (Codex Code Nos. SO 0702, 0699):• Where the sampling is done by hand select ripe heads. Where it is done
mechanically submit the seed to the laboratory. Take 12 heads or 1 kg of seed .
Coffee and cacao beans (Codex Code Nos. SB 0716, 0715):• Take samples in a manner reflecting common practice, quantity 1 kg. - The
freshly harvested produce is not normally required.
4.3.5 Herbs and Spices; Tea Leaves; Hops; Beer
• Take samples in a manner reflecting common practice.
• The freshly harvested produce is not normally required for tea although herbs,such as parsley and chives, should be sampled fresh. In the case of hops, bothfresh and dried cones should be supplied.
Table V.6 Sampling of Herbs and Spices; Tea Leaves; Hops and Beer
Commodity Codex Code No. Quantity, method of collection
Garden herbs and medicinal plants e.g. parsley,thyme
Group 027 Group028 Group 057
0.5 kg fresh
0.2 kg dry
Teas (dry leaves) Group 066 0.2 kg
Hops (dry cones) DH 1100 0.5 kg
Beer 1 litre
5. Sampling processed commodities
Where a commodity is normally processed between harvest and marketing, forexample by milling, pressing, fermentation, drying or extraction, data may berequired on the processed crop or its products. Details of the processing methodshould be supplied with the samples together with storage and handling histories.In such cases, the trials should be designed to provide samples with appropriateresidue levels so that the fate of residues can be studied during the processing.Sample separately any cleanings, husks or by-products which could be used foranimal feed.
6. Sampling stored commodities
Supervised trials of post-harvest treatments of stored products should be carriedout over a wide range of storage facilities, and the sampling technique must be
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carefully chosen if valid samples are to be obtained. Procedures for taking validsamples from most commodities in storage units are well established. Suchprocedures are acceptable in sampling for pesticide residue analysis and may beused if adequate references are given.
The sampling procedures are usually designed for three kinds of storageconditions.
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6.1 Sampling from bulk
Obtaining a representative sample from a (large) bulk container (e.g. of cerealgrains) is difficult: if possible, samples should be taken at frequent intervals fromthe stream during transfer into another container. A probe sample is notrepresentative but may be acceptable if:
• it is possible to reach every part of the storage container; and
• a larger number of individual samples are taken before mixing and reducing toproduce a final sample.
Pesticide residues are normally higher in the dust fraction and this should berecognised in the sampling procedure.
6.2 Sampling bagged commodities
Sampling of the commodity within a bag must be random. A representative samplefrom a large stack of bags can be obtained only if every bag is accessible. This isnot always possible in practice and the alternative is to obtain a sample from anumber of randomly chosen bags by probing. Since pesticide treatments are oftendirected to the surface of the bag, selective sampling to show the effect of theposition of the bag in the stack and the penetration of the pesticide into the bagmay be necessary.
6.3 Sampling fruit and vegetables in packing houses
Where post-harvest treatments are applied to fruit and vegetables in packinghouses, an adequate number of samples must be taken to determine the range ofresidue levels resulting from variations in the treatment process. The effects onresidue levels of concentration, temperature, duration of treatment, drying (afterdip treatments) and subsequent handling may need to be considered.
Post-harvest treated fruit and vegetables should be kept in, or packed in,commercial containers or punnets and stored at ambient or cool-room temperatureaccording to normal commercial practice. Samples should then be drawn foranalysis from the commercial containers at suitable intervals representing the timeexpected between treatment and subsequent marketing. The rate of disappearanceor degradation of some residues depends on whether the commodity is held in asealed or partly sealed container or is open to the air.
The size of samples are the same as shown in Tables V.1 - V.3.
7. Sample size reduction
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Large samples cannot be handled economically, especially if freezing and longtransport are involved. Take only that amount prescribed in the Study Plan.
Except cereal grains sampled on the conveyor belt or from the stream ofmaterial transferred from one large container to another, mixing of samples andsample size reduction at the field site is not recommended and should be avoided.
8. Sample packing and storage
Once packed and labelled, samples may be stored or immediately sent to theResidue Laboratory according to the nature of the sample. the stability of theresidue and the kind of study undertaken.
It is important that packing and shipment are carried out in such a way thatthe samples arrive as soon as possible (normally within 24-36 hours) after beingtaken and without change of any kind, e.g. deterioration, physical damage,contamination, loss of residue, or change in moisture content.
Storage and shipping should always be under deep-frozen conditions.
8.1 Packing
8.1.1 Containers
Individual samples should be placed in suitable containers, e.g. heavy polyethylenebags, and then put inside additional heavy paper bags and, where necessary, frozenor refrigerated as soon as possible after sampling according to the nature of thechemical involved. Polyethylene bags alone may become brittle in contact with dryice and therefore there is a risk of breakage and subsequent loss of the sample.
Avoid other plastic containers, or plastic-lined caps, unless made of“Teflon” or other inert plastic which does not interfere with the analytical method;laboratories have frequently experienced such interference, and PVC bags shouldbe avoided. If cans are used, they should first be checked to demonstrate theabsence of materials such as oil films, lacquers or resin from soldered joints thatcould interfere with analyses.
Glass containers should be used for liquid samples and should bethoroughly cleaned and rinsed with one or more suitable pesticide-free solventsuch as acetone, isopropyl alcohol or hexane, and dried before use. Pesticides canmigrate to the walls of a container and be adsorbed; hence even a glass container,after the sample is poured out, should be rinsed with solvent if the extraction is notmade in the container itself.
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In summary, any type of container or wrapping material should be checkedbefore use for possible interference with the analytical method and at the limit ofdetermination of the analysis.
Fasten boxes securely with strong twine, rope or tape.
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8.1.2 Shipment of samples
Non-perishable commodities containing residues that are known to be stable overthe period required to reach the laboratory can be shipped in a non-frozen state, butsamples should be protected against any effects which might cause degradation orcontamination.
Where samples need to be frozen, use shipping containers of polystyrenefoam, if available, as they are excellent for this purpose. If not available, use twocardboard boxes of slightly different size with insulation between. Properinsulation is essential to ensure samples arrive at the residue laboratory stillfrozen. Sufficient dry ice must be used for some to remain when samples arereceived at the residue laboratory. This usually requires a minimum of one kg ofdry ice per kg of sample. For journeys lasting more than two days, two kg of dryice or more per kg of sample may be required. Poorly insulated containers requiremore dry ice. Use caution in handling dry ice (gloves and ventilated work area).Packages must of course comply with transport regulations.
Frozen samples must never be allowed to thaw, either before or duringshipment. They must be shipped under conditions that permit their arrival at theresidue laboratory still solidly frozen.
Advise the consignee by telegram or telex of the full details of shipment ofsamples, including shipping document numbers and flight numbers, so that delay indelivery to the laboratory is avoided.
When samples have to be shipped across national boundaries, quarantineregulations must be observed and appropriate permits obtained well in advance ofdispatching samples.
8.2 Labels and records
Label each sample with the appropriate sample identification. The label and inkshould be such that the writing will not be illegible if the label becomes wet.Attach the label securely so that it cannot come loose during shipment, and placethe label so that it will not become wet from condensation.
Complete the Sampling Report (residue data sheets) clearly and accuratelywith all the requested trial details. Failure to do so may mean that data will not beacceptable. The completed sheets should be protected by enclosing them inprotective polythene bags which should be sent with the sample. Duplicate sheetsshould be kept by the sender.
Use a label on the outside of the shipping container stating the following:"Perishable Goods: Deliver immediately upon arrival" and 'This material is not fitfor human consumption".
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8.3 Sample reception and handling
Immediately upon arrival of the samples, the Residue Laboratory personnelshould:
- Verify that the copy of the Sampling Report is included with the samples.
- Check and report on the condition of the samples.
- Check to see that the samples match the details of the Sampling Report.
- Check the Sampling Report for accuracy (especially the rate and interval data)and verify that the information is complete.
- Check the Sampling Report to determine whether any special treatment or testingis indicated.
If there are any deviations of any consequence, or the Sampling Report isnot received or is incomplete (in such a way that a proper comparison is notpossible), the samples should be stored in the simplest form that will preserve theresidue and the crop. The trial organiser should then be contacted immediately todetermine how to proceed.
Note: it is dangerous to put packages containing dry ice into deep freeze.
8.4 Storage
Samples should be analysed as quickly as possible after collection before physicaland chemical changes occur. If prolonged storage is unavoidable, it is usuallypreferable to store the samples at a low temperature, preferably at or below -20°C.This removes the residue from contact with enzymes which might degrade thepesticide and also prevents further possibility of residues being "bound" in thetissue. Do not store samples (whole or homogenised) for analysis unless anadequate check has been made on the stability of the residue. Fumigant residuesamples need special attention and ideally should be analysed immediately onreceipt at the laboratory. Storage at -20°C is likely to be inadequate to preventloss of fumigant residues.
Studies of the stability of residues in samples, over the time and at thetemperature of storage, should be carried out with representative pesticides andsubstrates. When there is doubt about the stability of residues in storage, spikedcontrol samples should be held under the same conditions as the samples orextracts.
Light degrades many pesticides; it is therefore advisable to protect thesample and any solutions or extracts from needless exposure. Samples other than
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water should ordinarily be stored in a freezer, preferably at -20°C or below. Eventhen, physical and chemical changes may occur either in the sample or in theresidues sought. Extended storage in freezers can cause moisture to migrate to thesurface of the sample then to the freezer coils, slowly desiccating the sample. Thiseffect may be of importance if water content affects the subsequent analysis andcan affect the calculated residue concentration. Water samples should be storedslightly above freezing to avoid rupture of the container as a result of freezing.
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Appendix VI
PORTION OF COMMODITIESTO WHICH CODEX MAXIMUM RESIDUE LIMITS APPLY
AND WHICH IS ANALYSED9
INTRODUCTION
Codex Maximum Residue Limits are in most cases stated in terms of a specific whole rawagricultural commodity as it moves in international trade. In some instances, a qualification is includedthat describes the part of the raw agricultural commodity to which the maximum residue limit applies,for example, almonds on a shell-free basis and beans without pods. In other instances, suchqualifications are not provided. Therefore, unless otherwise specified, the portion of the rawagricultural commodity to which the MRL applies and which is to be prepared as the analytical samplefor the determination of pesticide residues is as described in the following table.
CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)
Group 1 - ROOT AND TUBER VEGETABLES(Codex Classification10 Group 016: Root and tuber vegetables)
Root and tuber vegetables are starchy foodsderived from the enlarged solid roots, tubers,corms or rhizomes, mostly subterranean, ofvarious species of plants. The entire vegetablemay be consumed.
9 Extracted from Codex Alimentarius Vol. 2A10 The number and categories of groups for portion of commodities do not always correspond to the groupingused by the current Codex Classification of Foods and Animal Feeds. The corresponding groups are given inbrackets.
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CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)Root and Tuber vegetables:
Beets rutabagasCarrots sugar beetsCeleriac sweet potatoesParsnips turnipsPotatoes yamsRadishes
Whole commodity after removingtops. Wash the roots or tubers incold running water, brushing gentlywith a soft brush to remove loosesoil and debris, if necessary, andthen dab lightly with clean tissuepaper to dry. For carrots, afterdrying the tops are carefully cut offwith a knife by cutting through thebottom of the stem at the lowestpoint of attachment of the outerpetioles. If an annulus of root tissueis thereby severed from hollow-crown roots, the material should bere-combined with the roots.
Group 2 - BULB VEGETABLES(Codex Classification Group: 009 Bulb vegetables)
Bulb vegetables are pungent, flavourful foodsderived from the fleshy scale bulbs or growthbuds of alliums of the lily family(Liliaceae). Theentire bulb may be consumed following removalof the parchment-like skin.
Remove adhering soil (e.g. byrinsing in running water or by gentlebrushing of the dry commodity)
Bulb vegetables:
Garlic onionsLeeks spring onions
Bulb/dry onions and garlic:Whole commodity after removal ofroots and whatever parchment skin iseasily detached.Leeks and spring onions:Whole vegetable after removal ofroots and adhering soil.
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CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)
Group 3 - LEAFY VEGETABLES (EXCEPT BRASSICA VEGETABLES)(Does not correspond to Codex Classification Group 013: Leafy vegetables (including Brassica leafyvegetables))
Leafy vegetables (except Group 4 vegetables)are foods derived from the leaves of a widevariety of edible plants including leafy parts ofGroup 1 vegetables. The entire leaf may beconsumed. Leafy vegetables of the brassicafamily are grouped separately.
Leafy vegetables:
beet leaves radish leavescorn salad spinachendive sugar beet leaveslettuce Swiss chard
Whole commodity after removal ofobviously decomposed or witheredleaves.
Group 4 - BRASSICA (COLE) LEAFY VEGETABLES(Does not correspond to Codex Classification Group 010: Brassica vegetables)
Brassica (cole) leafy vegetables are foodsderived from the leafy parts, stems and immatureinflorescences of plants commonly known andbotanically classified as brassicas and alsoknown as cole vegetables. The entire vegetablemay be consumed.
Brassica leafy vegetables:
broccoli cauliflowerBrussels sprouts collardscabbage kalescabbage, Chinese kohlrabicabbage, red mustard greenscabbage, Savoy
Whole commodity after removal ofobviously decomposed or witheredleaves. For cauliflower and headedbroccoli analyse flower head andstems, discarding leaves; forBrussels sprouts analyse "buttons"only.
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CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)
Group 5 - STEM VEGETABLES(Codex Classification Group 017: Stalk and stem vegetables)
Stem vegetables are foods derived from theedible stems or shoots of a variety of plants.
Stem vegetables:
Artichoke chicory (witloof)Celery rhubarb
Whole commodity after removal ofobviously decomposed or witheredleaves.Rhubarb and asparagus: stems only.Celery and asparagus: removeadhering soil (e.g. by rinsing inrunning water or by gentle brushingof the dry commodity).
Group 6 - LEGUME VEGETABLES(Codex Classification Group 014: Legume vegetables Group 015: Pulses)
Legume vegetables are derived from the dried orsucculent seeds and immature pods orleguminous plants commonly known as beansand peas. Succulent forms may be consumed aswhole pods or as the shelled product. Legumefodder is in Group 18.
Legume vegetables:
Beans navy beansbroad beans runner beansdwarf beans snapbeansFrench beans soybeansgreen beans peaskidney beans cow peasLima beans sugar peas
Whole commodity.
Group 7 - FRUITING VEGETABLES - EDIBLE PEEL(Combination of Codex Classification Groups 011: Fruiting vegetables, Cucurbits; 012 Fruiting vegetables otherthan Cucurbits)
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CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)
Fruiting vegetables - edible peel are derivedfrom the immature or mature fruits of variousplants, usually annual vines or bushes. The entirefruiting vegetables may be consumed.
Fruiting vegetables - edible peel:
cucumber pepperegg plant summer squashgherkin tomatookra mushroom11
Whole commodity after removal ofstems.
Group 8 - FRUITING VEGETABLES - INEDIBLE PEEL(Codex Classification Group 011 Fruiting vegetables, Cucurbits)
Fruiting vegetables - inedible peel:cantaloupe squashmelon watermelonpumpkin winter squash
Whole commodity after removal ofstems.
Group 9 - CITRUS FRUITS(Codex Classification Group 001 Citrus fruits)
Citrus fruits are produced by trees of theRutaceae family and are characterized byaromatic oily peel, globular form and interiorsegments of juice-filled vesicles. The fruit isfully exposed to pesticides during the growingseason. The fruit pulp may be consumed insucculent form and as a beverage. The entirefruit may be used for preserving.
Group 8 - FRUITING VEGETABLES - INEDIBLE PEEL(Codex Classification Group 011 Fruiting vegetables, Cucurbits)
Fruiting vegetables - inedible peel:
cantaloupe squashmelon watermelonpumpkin winter squash
Whole commodity after removal ofstems.
11 Mushroom is not included in the commodities listed in the original document
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CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)
Group 9 - CITRUS FRUITS(Codex Classification Group 001 Citrus fruits)
Citrus fruits are produced by trees of theRutaceae family and are characterized byaromatic oily peel, globular form and interiorsegments of juice-filled vesicles. The fruit isfully exposed to pesticides during the growingseason. The fruit pulp may be consumed insucculent form and as a beverage. The entirefruit may be used for preserving.
Citrus fruits: Whole commodity.
Group 10 - POME FRUITS(Codex Classification Group 002 Pome fruits)
Pome fruits are produced by trees related to thegenus Pyrus of the rose family (Rosaceae). Theyare characterized by fleshy tissue surrounding acore consisting of parchment-like carpelsenclosing the seed. The entire fruit, except thecore, may be consumed in the succulent form orafter processing.
Pome fruits:
Apple quincePear
Whole commodity after removal ofstems.
Group 11 - STONE FRUITS(Codex Classification Group 003 Stone fruits)
Stone fruits are produced by trees related to thegenus Prunus of the rose family (Rosaceae)characterized by fleshy tissue surrounding asingle hard-shelled seed. The entire fruit, exceptseed, may be consumed in a succulent orprocessed form.
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CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)Stone fruits:
Apricots nectarinesCherries peachessour cherries plumssweet cherries
Whole commodity after removal ofstems and stones but the residuecalculated and expressed on thewhole commodity without stem.
Group 12 - SMALL FRUITS AND BERRIES(Codex Classification Group 004: Berries and other small fruits )
Small fruits and berries are derived from avariety of plants whose fruit is characterized by ahigh surface-weight ratio. The entire fruit, oftenincluding seed, may be consumed in a succulentor processed form.
Small fruits and berries:
blackberries gooseberriesblueberries grapesboysenberries loganberriescranberries raspberriescurrants strawberriesdewberries
Whole commodity after removal ofcaps and stems. Currants: fruit withstems.
Group 13 - ASSORTED FRUITS - EDIBLE PEEL(Codex Classification Group 005: Assorted tropical and sub-tropical fruit - edible peel)
Assorted fruits - edible peel are derived from theimmature or mature fruits of a variety of plants,usually shrubs or trees from tropical orsubtropical regions. The whole fruit may beconsumed in a succulent or processed form.
Assorted fruits - edible peel:
dates olivesfigs
Dates and olives: whole commodityafter removal of stems and stonesbut residue calculated and expressedon the whole fruit.Figs: Whole commodity.
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CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)
Group 14 - ASSORTED FRUITS - INEDIBLE PEEL(Codex Classification Group 006: Assorted tropical and sub-tropical fruit - inedible peel)
Assorted fruits - inedible peel are derived fromthe immature or mature fruits of different kindsof plants, usually shrubs or trees from tropicalor subtropical regions. Edible portion isprotected by skin, peel or husk. Fruit may beconsumed in a fresh or processed form.
Assorted fruits - inedible peel:
Avocados mangoesBananas papayasGuavas passion fruitskiwi fruit pineapples
Whole commodity unless qualified.Pineapples: after removal of crown.Avocado and mangoes: wholecommodity after removal of stonebut calculated on whole fruit.Bananas: after removal of crowntissue and stalks.
Group 15 - CEREAL GRAINS(Codex Classification Group 020: Cereal grains)
Cereal grains are derived from the clusters ofstarchy seeds produced by a variety of plantsprimarily of the grass family (Gramineae). Husksare removed before consumption.
Cereal grains:
Barley ryeMaize sorghumOats sweet cornRice wheat
Whole commodity.Fresh corn and sweet corn: kernelsplus cob without husk.
Group 16 - STALK AND STEM CROPS(Codex Classification Group 051: Straw, fodder and forage of cereal grains and grasses)
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CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)Stalk and stem crops are various kinds of plants,mostly of the grass family (Gramineae)cultivated extensively as animal feed and for theproduction of sugar. Stems and stalks used foranimal feeds are consumed as succulent forage,silage, or as dried fodder or hay. Sugar crops areprocessed.
Stalk and stem crops:
Barley fodder maize fodder and straw sorghum foddergrass fodders
Whole commodity.
Group 17 - LEGUME OILSEEDS(Part of Codex Classification Group 023: Nuts and seeds)
Legume oilseeds are mature seeds from legumescultivated for processing into edible vegetableoil or for direct use as human food.
Legume oilseeds:
peanuts
Whole kernel after removal of shell.
Group 18 - LEGUME ANIMAL FEEDS(Codex Classification Group 050: Legume animal feeds)
Legume animal feeds are various species oflegumes used for animal forage, grazing, fodder,hay or silage with or without seed. Legumeanimal feeds are consumed as succulent forageor as dried fodder or hay.
Legume and animal feeds:
alfalfa fodder peanut fodderbean fodder pea fodderclover fodder soybean fodder
Whole commodity.
Group 19 - TREE NUTS(Codex Classification Group 022: Tree nuts)
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CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)
Tree nuts are the seeds of a variety of trees andshrubs which are characterized by a hard, inedibleshell enclosing an oil seed. The edible portionof the nut is consumed in succulent, dried orprocessed form.
Tree nuts:
almonds macadamia nutschestnuts pecansfilberts walnuts
Whole commodity after removal ofshell.Chestnuts: whole in skin.
Group 20 - OILSEED(Codex Classification Group 23: Nuts and seeds)
Oilseed consists of the seed from a variety ofplants used in the production of edible vegetableoils. Some important vegetable oilseeds are by-products of fibre or fruit crops.
Oilseed:
Cottonseed safflowerseedLinseed sunflowerseedRapeseed
Whole commodity.
Group 21 - TROPICAL SEEDS(Codex Classification Group 024: Seed for beverages and sweets)
Tropical seeds consist of the seeds from severaltropical and semitropical trees and shrubs mostlyused in the production of beverages andconfections. Tropical seeds are consumed afterprocessing.
Tropical seeds:
cacao beans coffee beans
Whole commodity.
Group 22 - HERBS(Codex Classification Group 027: Herbs)
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CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)
Herbs consist of leaves, stems and roots from avariety of herbaceous plants used in relativelysmall amounts to flavour other foods. They areconsumed in succulent or dried form ascomponents of other foods.
Herbs: Whole commodity.
Group 23 - SPICES(Codex Classification Group 028: Spices)
Spices consist of aromatic seeds, roots, fruitsand berries from a variety of plants used inrelatively small amounts to flavour other foods.They are consumed primarily in the dried form ascomponents of other foods.
Spices: Whole commodity.
Group 24 - TEAS(Codex Classification Group 066: Teas)
Teas are derived from the leaves of severalplants, but principally Camellia sinensis. They areused in the preparation of infusions forconsumption as stimulating beverages. They areconsumed as extracts of the dried or processedproduct.
Teas: Whole commodity.
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CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)
Group 25 - MEATS(Codex Classification Group 030: Meet)
Meats are the muscular tissue, including adheringfatty tissue, from animal carcasses prepared forwholesale distribution. The entire product maybe consumed.
Meats:
carcass meat (and carcass fat)carcass meat of cattlecarcass meat of goatscarcass meat of horsescarcass meat of pigscarcass meat of sheep
Whole commodity. (For fat solublepesticides a portion of carcass fat isanalysed and MRLs apply to carcassfat.)12
Group 26 - ANIMAL FATS(Codex Classification Group 031: Mammalian fats)
Animal fats are the rendered or extracted fatfrom the fatty tissue of animals. The entireproduct may be consumed.
Animal fats:
cattle fat sheep fatpig fat
Whole commodity.
Group 27 - MEAT BYPRODUCTS(Codex Classification Group 0032: Edible offal (mammalian))
Meat byproducts are edible tissues and organs,other than meat and animal fat, from slaughteredanimals as prepared for wholesale distribution.Examples: liver, kidney, tongue, heart. Theentire product may be consumed.
12 For milk and milk products regarding fat soluble pesticides see Section 1 of this Volume.
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CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)Meat byproducts (such as liver, kidney, etc.):
cattle meat byproductsgoat meat byproductspig meat byproductssheep meat byproducts
Whole commodity.
Group 28 - MILKS(Codex Classification Group 033: Milks)
Milks are the mammary secretions of variousspecies of lactating herbivorous ruminantanimals, usually domesticated. The entireproduct may be consumed.
Milks:13 Whole commodity. For fat-solublecompounds a portion of the fat isanalysed but the residue is expressedon a whole commodity basis on theassumption that milk contains 4%fat.
Group 29 - MILK FATS(Codex Classification Group 086: Milk fats)
Milk fats are the fats rendered or extracted frommilk.
Milk fats: Whole commodity.
Group 30 - POULTRY MEATS(Codex Classification Group 036: Poultry meat)
Poultry meats are the muscular tissues, includingadhering fat and skin, from poultry carcasses asprepared for wholesale distribution. The entireproduct may be consumed.
13 For milk and milk products regarding fat soluble pesticides see Section 1 of this Volume.
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CLASSIFICATION OF COMMODITIES PORTION OF COMMODITY TO WHICH
THE CODEX MRL APPLIES (AND
WHICH IS ANALYSED)Poultry Meats: Whole commodity. (For fat soluble
pesticides a portion of carcass fat isanalysed and MRLs apply to carcassfat.)
Group 31 - POULTRY FATS(Codex Classification Group 037: Poultry fat)
Poultry fats are the rendered or extracted fatsfrom fatty tissues of poultry. The entire productmay be consumed.
Poultry fats: Whole commodity.
Group 32 - POULTRY BYPRODUCTS(Codex Classification Group 038: Poultry, edible offal of)
Poultry byproducts are edible tissue and organs,other than poultry meat and poultry fat, fromslaughtered poultry.
Poultry byproducts: Whole commodity.
Group 33 - EGGS(Codex Classification Group 039: Eggs)
Eggs are the fresh edible portion of thereproductive body of several avian species. Theedible portion includes egg white and egg yolkafter removal of the shell.
Eggs: Whole egg whites and yolkscombined after removal of shells.
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Appendix VII
STANDARDIZED FORMAT FORORGANIZING THE DATA DIRECTORY (INDEX) OF
INFORMATIONTO BE SUBMITTED FOR EVALUATION
1. BACKGROUND INFORMATION
Volume number1.1 Identity
1.2 Physical and chemical properties1.2.1 Vapour pressure
Author, A.U. Year. Study Title. Study number. Company. (Volume)1.2.2 Octanol-water partition coefficient
Author, A.B. Year. Study Title. Study number. Company. (Volume)Author, C.D. Year. Study Title. Study number. Company. (Volume)
1.3 FormulationsReference (author, etc.,)
2. METABOLISM AND ENVIRONMENT FATE
The following are suggested as the principal sub-headings; further topics (e.g. rotationalcrop studies) may be needed, depending on the pesticide under review. The proposedsubdivisions are indicated under those headings where generally a number of reports fora range of commodities are provided.
2.1 Animal metabolism subdivided according to laboratory animal, livestock, poultryAuthor, A.B. Year. Study Title. Study number. Company. (Volume)Author, C.D. Year. Study Title. Study number. Company. (Volume)
2.2 Plant metabolism subdivided, where necessary, according to commodityReferences (author etc.,) and volume numbers
2.3 Environmental fate in soilReferences and volume numbers
2.4 Environmental fate in water/sediment systemsReferences and volume numbers
3. METHODS OF RESIDUE ANALYSIS
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3.1 Analytical methodsEnforcement MethodsSpecialized MethodsSubheadings by substrate (e.g. commodity, soil etc.) may be of use.References and volume numbers
3.2 Stability of residues in stored analytical samplesSubdivided, where necessary, according to commodityReferences and volume numbers
3.3 Residue definition
4. USE PATTERNVolume numberList of crops for which Good Agricultural Practice (GAP ) information isavailable, the relevant country(ies) (listed alphabetically), and whether labels willbe available.
5. RESIDUES RESULTING FROM SUPERVISED TRIALSSubheadings by commodity organized according to the Codex ClassificationThis section should include animal (livestock and poultry) transfer studies.
Citrus fruitslemons
References and volume numbersoranges
References and volume numberstangelos
References and volume numbers
Pome fruitsapples
References and volume numberspears
References and volume numbers
6. FATE OF RESIDUES IN STORAGE AND PROCESSING
6.1 In storageSubdivided, where necessary, according to commodity.References and volume numbers
6.2 In processingSubdivided, where necessary, according to commodityReferences and volume numbers
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6.3 Residues in the edible portions of food commodities
Reference(s) and Volume number
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7. RESIDUES IN FOOD IN COMMERCE OR AT CONSUMPTION
References and volume numbers
8. NATIONAL RESIDUE LIMITS
Volume numberA list of the countries for which this information is available should be included.
Format for references:
In each section the references should be in hierarchical preferential order of 1) author's namealphabetically, 2) year, 3) study number. The year is the year of publication of the study (or project) in theresidue evaluations. The study (or project) number and company name should be related, i.e. if the studynumber quoted is that of the contracted laboratory, the contracted laboratory's name should be given in thereference, not the name of the sponsoring company.
Fischer, R., and Schulze, E.-F. 1983a. The effect of Hoe 02782 O F AT202 (fentin acetate, active ingredient 96.4%)on Salmo gairdneri (Rainbow trout) in a static test. Hoechst Pfl. Fo. Biol., Germany Rep. OEK 83 001E.Unpublished.
Fischer, R., and Schulze, E.-F. 1983b. The effect of Hoe 29664 O F AT205 fentin hydroxide, active ingredient97.0%) on Salmo gairdneri (Rainbow trout) in a static test. Hoechst Pfl. Fo. Biol., Germany Rep. OEK 83 028E.Unpublished.
Gildemeister, H., Bürkle, W.L. and Sochor, H. 1985. Hoe 029664-14-C. Anaerobic soil metabolism study with thefungicide triphenyltin hydroxide (TPTH). Hoechst Analyt. Labor., Germany Rep (B) 221/85. Unpublished.
MacDougall, D. 1964. Guthion. In: Zweig, G., Analytical Methods for Pesticides, Plant Growth Regulators andFood Additives, Vol. II, Academic Press, New York, London.
Meagher, W.R., Adams, J.M., Anderson, C.A. and MacDougall, D. 1960. Colorimetric determination of Guthionresidues in crops. J. Agric. Food Chem . 8, 282-6
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Appendix VIII
PESTICIDE INFORMATION FOR CCPR WORKING GROUP ON PRIORITIES14
for evaluation _______
for re-evaluation _______
1. NAME:
2. STRUCTURAL FORMULA:
3. CHEMICAL NAME:
4. TRADE NAME:
5. NAMES AND ADDRESSES OF BASIC PRODUCERS:
6. JUSTIFICATION FOR USE:
7. USES: MAJOR
MINOR
8. COMMODITIES MOVING IN INTERNATIONAL TRADE AND LEVELS OF RESIDUES:
9. COUNTRIES WHERE PESTICIDE IS REGISTERED:
10. NATIONAL MAXIMUM RESIDUE LIMITS:
11. COMMODITIES FOR WHICH THE NEED FOR ESTABLISHING CODEX MRLsARE RECOGNIZED:
12. MAJOR INTERNATIONAL USE PATTERN:
13. LIST OF DATA (TOXICOLOGY, METABOLISM, RESIDUE) AVAILABLE:
14. DATE DATA COULD BE SUBMITTED TO THE JMPR:
15. PROPOSAL FOR INCLUSION SUBMITTED BY (COUNTRY):
14 This information is to be provided by Codex member countries for inclusion of a pesticide in the Codex Priority
List.
FAO Manual on the Submission and Evaluation of Pesticide Residues Data Appendix VIII
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FAO Manual on the Submission and Evaluation of Pesticide Residues Data Appendix IX
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Appendix IX
MAXIMUM PROPORTION OF AGRICULTURAL COMMODITIES INANIMAL FEED
Table 1.
Raw agricultural commodities and feedstuff derived from crop (US data)
CropRaw AgriculturalCommodity
ProcessedCommodity
Percent of Livestock Diet (1,2)
Feedstuff % DM (3) Beef Cattle Dairy Cattle Poultry Swine
Alfafa (4) forage
hay
seed (5)
forage 35 70 60 NU (6) NU
hay 89 70 60 NU NU
meal (7) 89 25 50 10 10
silage (8) 40 70 60 NU NU
Almond nutmeathulls
hulls 90 10 10 NU NU
Apple fruit pomace, wet juice pomace, wet 40 40 20 NU NU
Barley (9) grain (10)hay
straw
pearled barleyflourbran
grain (10)hay
straw
888889
502510
406060
75NUNU
80NUNU
Beet, sugar roottops (leaves)
sugar, refined (11)pulp, driedmolasses
tops (leaves)pulp, driedmolasses
238875
202010
102010
NUNUNU
NUNUNU
Canola seed mealoil, refined
meal 88 15 15 15 15
Carrot root culls (12) 12 25 25 NU 10
Citrus fruit, whole pulp, dried oiljuice
pulp, dried 91 20 20 NU NU
Clover (13) forage
hay
forage 30 30 60 NU NU
CropRaw AgriculturalCommodity
ProcessedCommodity
Percent of Livestock Diet (1,2)
Feedstuff % DM (3) Beef Cattle Dairy Cattle Poultry Swine
hay 89 30 60 NU NU
silage (14) 30 30 60 NU NU
Corn, field grainstarch (18)
wet milling:oil, refined
grain 88 80 40 80 80
forage forage (15) 40 40 50 NU NU
stover (16)gritsflour
dry milling:meal
oil, refined
stover (16) 83 25 15 NU NU
aspirated grainfractions (17)
aspirated grainfractions (17)
85 20 20 NU 20
milled by-products (19) 85 50 25 60 75
Corn, pop grain grain 88 80 40 80 40
stover (16) stover (16) 85 25 15 NU NU
Corn, sweet (20) sweet corn, K +CWHR (21)
forage (22) 48 40 50 NU NU
stover (16) cannery waste (23) 30 35 20 NU NU
forage (22) stover (16) 83 25 15 NU NU
Cotton undelinted seed meal undelinted seed 88 25 25 NU NU
cotton gin byproducts(24)
hulls cotton gin byproducts(24)
90 20 20 NU NU
oil, refined meal 89 15 15 20 15
CropRaw AgriculturalCommodity
ProcessedCommodity
Percent of Livestock Diet (1,2)
Feedstuff % DM (3) Beef Cattle Dairy Cattle Poultry Swine
Cotton hulls 90 20 15 NU NU
Cowpea (25) seed seed 88 20 20 10 50
hay hay 86 40 40 NU NU
forage forage 30 40 40 NU 15
Crownvetch (26) forage forage 30 20 60 NU NU
hay hay 90 20 60 NU NU
Flax seed meal meal 88 10 10 30 10
Grass (pasture &rangeland) (27)
forage forage 25 60 60 NU NU
hay hay 88 60 60 NU NU
silage (28) 40 60 60 NU NU
Lespedeza (29) forage forage 22 20 60 NU NU
hay hay 88 20 60 NU NU
Lupin seed seed 88 20 20 15 20
Millet (30) grain (31) flour (33) grain (31) 88 50 40 70 75
forage forage 30 25 60 NU NU
hay hay 85 25 60 NU NU
straw (32) straw (32) 90 10 10 NU NU
Oats (34) grain (10) flour grain (10) 89 50 40 80 80
forage groats/ rolled oats forage 30 25 60 NU NU
hay hay 90 25 60 NU NU
CropRaw AgriculturalCommodity
ProcessedCommodity
Percent of Livestock Diet (1,2)
Feedstuff % DM (3) Beef Cattle Dairy Cattle Poultry Swine
straw straw 90 10 10 NU NU
Pea, field (35) seed seed 90 20 20 20 20
vines vines 25 25 50 NU NU
hay hay 88 25 50 NU NU
silage (36) 40 25 50 NU NU
Peanut nutmeat meal meal 85 15 15 25 15
hay (37) oil, refined hay (37) (R) (38) 85 25 50 NU NU
Pineapple fruit process residue (39)
juiceprocess residue (39) 25 30 20 NU NU
Potato tuber granules/ flakes (40) culls 20 75 40 NU 50
chipspeel, wet
processed potato waste(41)
15 75 40 NU NU
Rape seed meal (42) meal 88 15 15 15 15
forage forage 30 30 30 NU NU
Rice (43) grain (10) polished rice grain (10) 88 40 40 60 65
straw hulls straw 90 10 10 NU NU
bran hulls 90 10 10 15 NU
bran 90 15 15 25 15
Rye (44) grain (45) flour grain (45) 88 40 40 50 80
forage bran forage 30 25 60 NU NU
CropRaw AgriculturalCommodity
ProcessedCommodity
Percent of Livestock Diet (1,2)
Feedstuff % DM (3) Beef Cattle Dairy Cattle Poultry Swine
Rye straw straw 88 10 10 NU NU
Safflower seed mealoil, refined
meal 91 10 10 25 25
Sorghum, grain grain flour (46) grain 86 40 40 80 90
forage (15) forage (15) 35 40 50 NU NU
stover (16) stover (16) 88 25 15 NU NU
aspirated grainfractions (17)
aspirated grain fractions(17)
85 20 20 NU 20
Soybean (47) seed meal seed 89 15 15 20 25
forage hulls forage (R) (38) 35 30 30 NU NU
hay oil, refined hay (R) (38) 85 30 30 NU NU
aspirated grainfractions (17)
aspirated grain fractions(17)
85 20 20 NU 20
meal 92 15 15 40 25
hulls 90 20 20 20 NU
silage (48) 30 30 30 NU NU
Sugarcane (49) cane molasses (50) sugar,refined (11)
molasses (50) 75 10 10 NU NU
Sunflower seed mealoil (refined)
meal 92 15 15 30 20
Trefoil (51) forage forage 30 20 60 NU 10
hay hay 85 20 60 NU NU
CropRaw AgriculturalCommodity
ProcessedCommodity
Percent of Livestock Diet (1,2)
Feedstuff % DM (3) Beef Cattle Dairy Cattle Poultry Swine
Turnip root root 15 75 20 NU 40
tops (leaves tops (leaves 30 50 30 NU NU
Vetch (52) forage forage 30 20 60 NU NU
hay hay 85 20 60 NU NU
Wheat (53) (54) grain (45) bran grain (45) 89 50 40 80 80
forage flour forage 25 25 60 NU NU
hay middlings hay 88 25 60 NU NU
straw shorts straw 88 10 10 NU NU
aspirated grainfractions (17)
germ aspirated grain fractions(17)
85 20 20 NU NU
milled byproducts (55) 88 40 50 50 50
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(ii) Table notes. The following notes are referenced in the table.
(1) Percent of Livestock Diet. For percentages of feedstuffs in livestock dietsother than those listed here, contact one of the Chemistry Branches, Health EffectsDivision, Mail Code 7509C, Office of Pesticide Programs, Environmental ProtectionAgency, 401 M. St. S.W., Washington, DC 20460, USA.
(2) Percent of Livestock Diet. Maximum percent of diet on a dry-weight basisfor finishing beef and lactating dairy cattle, and on an as-fed basis for poultry andfinishing swine (hogs).
(3) % DM (percentage dry matter). For beef and dairy feedstuffs, thepercentage of moisture should be reported for representative samples of raw agriculturaland processed commodities.
(4) Alfalfa. Residue data are needed from a minimum of three cuttings, unlessclimatic conditions restrict the number of cuttings. Cut sample at late bud to earlybloom stage (first cut), and/or at early (one-tenth) bloom stage (later cuts).
(5) Alfalfa seed. For registered uses on alfalfa grown for seed, residue datashould be provided on seed, forage and hay; for all other uses data should only beprovided on forage and hay.
(6) NU. Not used or a minor feedstuff (less than 10 percent of livestock diet).
(7) Alfalfa meal. Residue data are not needed for meal; however, the mealshould be included in the livestock diet, using the hay tolerance level. Hay should befield-dried to a moisture content of 10 to 20 percent.
(8) Alfalfa silage. Residue data on silage are optional, but are desirable forassessment of dietary exposure. Cut at late bud to one-tenth bloom stage for alfalfa,allow to wilt to approximately 60 percent moisture, then chop fine, pack tight, and allowto ferment for three weeks maximum in an air-tight environment until it reaches Ph 4.This applies both to silage and haylage. In the absence of silage data, residues in foragewill be used for silage, with correction for dry matter.
(9) Barley hay. Cut when the grain is in the milk to soft dough stage. Hayshould be field-dried to a moisture content of 10 to 20 percent. Barley straw. Plantresidue (dried stalks or stems with leaves) left after the grain has been harvested(threshed).
(10) Barley, grain, oat grain and rice grain. Kernel (caryopsis) plus hull (lemmaand palea).
(11) Beet, sugar. Residue data may be applied for raw sugar or refined sugar, orboth raw and refined. Sugarcane. Residue data may be supplied in the same manner.
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(12) Carrot culls. Data for raw agricultural commodities will cover residue onculls.
(13) Clover forage. Cut sample at the 4-8 inch to pre-bloom stage, atapproximately 30 percent DM. Clover hay. Cut at early to full bloom stage. Hay shouldbe field-dried to a moisture content of 10 to 20 percent. Residue data for clover seedsare not needed.
(14) Clover silage. Residue data on silage are optional, but are desirable forassessment of dietary exposure. Cut sample at early to one-fourth bloom for clover,allow to wilt to approximately 60 percent moisture, then chop fine, pack tight, and allowto ferment for 3 weeks maximum in an air-tight environment until it reaches Ph 4. Thisapplies to both silage and haylage. In the absence of silage data, residues in forage willbe used for silage, with correction for dry matter.
(15) Field corn forage. Cut sample (whole aerial portion of the plant) at latedough/early dent stage (black ring/layer stage for corn only). Sorghum forage. Cut sample(whole aerial portion of the plant) at soft dough to hard dough stage. Forage samplesshould be analyzed as is, or may be analyzed after ensiling for 3 weeks maximum, andreaching Ph 5 or less, with correction for dry matter.
(16) Corn stover. Mature dried stalks from which the grain or whole ear (cob +grain) have been removed; containing 80 to 85 percent DM. Sorghum stover. Maturedried stalks from which the grain has been removed; containing approximately 85 percentDM.
(17) Aspirated grain fractions (previously called grain dust). Dust collected atgrain elevators for environmental and safety reasons. Residue data should be providedfor any post-harvest use on corn, sorghum, soybeans or wheat). For a pre-harvest useafter the reproduction stage beings and seed heads are formed, data are needed unlessresidues in the grain are less than the limit of quantitation of the analytical method. Fora pre-harvest use during the vegetative stage (before the reproduction stage beings), datawill not normally be needed unless the plant metabolism or processing study sows aconcentration of residues of regulatory concern in an outer seed coat (e.g. wheat bran,soybean hulls).
(18) Corn starch. Residue data for starch will be used for corn syrup. Petitionsmay also provide data on syrup for a more accurate assessment of dietary exposure.
(19) Corn milled byproducts. Use residue data for corn dry-milled processedcommodities having the highest residues, excluding oils.
(20) Sweet corn. Residue data on early sampled field corn should suffice toprovide residue data on sweet corn, provided the residue data are generated at the milk
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stage on kernel plus cob with husk removed and there are adequate numbers of trials andgeographical representation from the sweet corn growing regions.
(21) Sweet corn (K + CWHR). Kernels plus cob with husks removed.
(22) Sweet corn forage. Samples should be taken when sweet corn is normallyharvested for fresh market, and may or may not include the ears. Petitioners may analyzethe freshly cut samples, or may analyze the ensiled samples after ensiling for 3 weeksmaximum, and reaching pH 5 or less, with correction for percent dry matter.
(23) Sweet corn cannery waste. Includes husks, leaves, cobs and kernels.Residue data for forage will be used for sweet corn cannery waste.
(24) Cotton gin byproducts (commonly called gin trash). Include the plantresidues from ginning cotton, and consist of burrs, leaves, stems, lint, immature seeds,and sand and/or dirt. Cotton must be harvested by commercial equipment (stripper andmechanical picker) to provide an adequate representation of plant residue for the ginningprocess. At least three field trials for each type of harvesting (stripper and picker) areneeded, for a total of six field trials.
(25) Cowpea forage. Cut sample at 6 inch to pre-bloom stage, at approximately30 percent DM. Cowpea hay. Cut when pods are one-half to fully mature. Hay should befield-dried to a moisture content of 10 to 20 percent.
(26) Crownvetch forage. Cut sample at 6 inch to pre-bloom stage, atapproximately 30 percent DM. Crownvetch hay. Cut at full bloom stage. Hay should befield-dried to a moisture content of 10 to 20 percent.
(27) Grass. Zero day crop field residue data for grasses cut for forage shouldbe provided unless it is not feasible, e.g. pre-plant/pre-emergent pesticide uses. Areasonable interval before cutting for hay is allowed. Grass forage. Cut sample at 6-8inch to boot stage, at approximately 25 percent DM. Grass hay. Cut in boot stage. Hayshould be field-dried to a moisture content of 10 to 20 percent. Grasses includebarnyardgrass, bentgrass, Bermudagrass, Kentucky bluegrass, big bluestem, smoothbromegrass, buffalograss, reed canarygrass, crabgrass, cupgrass, dallisgrass, sanddropseed, meadow foxtail, eastern gramagrass, side-oats grama, guineagrass, Indiangrass,Johnsongrass, lovegrass, napiergrass, oatgrass, orchardgrass, pangolagrass, redtop, Italianryegrass, sprangleton, squirreltailgrass, stargrass, switchgrass, timothy, crestedwheatgrass, and wildryegrass. Also included are sudangrass and sorghum forages andtheir hybrids. For grass grown for seed only, PGIs (pre-grazing intervals) and (pre-harvest intervals) are acceptable. Residue data may be based on the regrowth afterharvesting the seed.
(28) Grass silage. Residue data on silage are optional, but are desirable forassessment of dietary exposure. Cut sample at boot to early head stage, allow to wilt to55-65 percent moisture, then chop fine, pack tight, and allow to ferment for 3 weeks
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maximum in an air-tight environment until it reaches pH 4. In the absence of silage data,residues in forage will be used for silage, with correction for dry matter.
(29) Lespedeza forage. Cut sample at 4-6 inch to pre-bloom stage, at 20-25percent DM. Lespedeza hay: Annual/Korean. Cut at early blossom to full bloom stage.Sericea. Cut when 12-15 inches tall. Hay should be field-dried to a moisture content of10-20 percent.
(30) Millet forage. Cut sample at 10 inches to early boot stage, at approximately30 percent DM. Millet hay. Cut at early boot stage or approximately 40 inches tall,whichever is reached first. Hay should be field-dried to a moisture content of 10 to 20percent. Millet includes pearl millet.
(31) Millet grain. Kernel plus hull (lemma and palea). Pearl millet. Kernel withhull (lemma and palea) removed.
(32) Millet straw. Data are required for proso millet only. Proso millet straw.Plant residue (dried stalks or stems with leaves) left after the grain has been harvested.
(33) Millet flour. Not produced significantly in the United States for humanconsumption. Residue data are not needed at this time.
(34) Oats forage. Cut sample between tillering to stem elongation (jointing)stage. Oats hay. Cut sample from early flower to soft dough stage. Hay should be field-dried to a moisture content of 10 to 20 percent. Oats straw. Cut plant residue (driedstalks or stems with leaves) left after the grain has been harvested (threshed).
(35) Pea, field. Does not include the canning field pea cultivars used in humanfood. Includes cultivars grown for livestock feeding only such as Austrian winter pea.Field pea vines. Cut sample anytime after pods begin to form, at approximately 25percent DM. Field pea hay. Succulent plant cut from full bloom through pod formation.Hay should be field-dried to a moisture content of 10 to 20 percent.
(36) Pea, field, silage. Use field pea vine residue data for field pea silage withcorrection for dry matter.
(37) Peanut hay. Peanut hay consists of the dried vines and leaves left after themechanical harvesting of peanuts from vines that have been sun-dried to a moisturecontent of 10 to 20 percent.
(38) (R): Label restrictions against feeding may be allowed, e.g. Do not feedgreen immature growing plants to livestock, or Do not harvest for livestock feed.
(39) Pineapple process residue (also known as wet bran). A wet waste byproductfrom the fresh-cut product line that includes pineapple tops (minus crown), bottoms,
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peels, any trimmings with peel cut up, and the pulp (left after squeezing for juice); it caninclude culls.
(40) Potato granules/flakes. Residue data may be provided for either.
(41) Potato processed waste. Tolerance levels for wet peel should be used fordietary burden calculations. Residue data may be provided from actual processed potatowaste generated using a pilot or commercial scale process that gives the highestpercentage of wet peel in the waste.
(42) Rapeseed meal. Residue data are not needed for rapeseed oil since it isproduced for industrial uses and is not an edible oil. The edible is only produced fromcanola (See canola).
(43) Rice straw. Stubble (basal portion of the stems) left standing afterharvesting the grain.
(44) Rye forage. Cut sample at 6-8 inch stage to stem elongation (jointing)stage, at approximately 30 percent DM. Rye straw. Cut plant residue (dried stalks orstems with leaves) left after the grain has been harvested (threshed).
(45) Rye grain or wheat grain. Kernel (caryopsis) with hull (lemma and palea)removed.
(46) Sorghum flour. Residue data are not needed at this time since sorghumflour is used exclusively in the United States as a component for drywall, and not aseither a human food or a feedstuff. However, because 50 percent of the worldwidesorghum production goes toward human consumption, data may be needed at a later date.
(47) Soybean forage. Cut samples at 6-8 inches tall (sixth node) to beginningpod formation, at approximately 35 percent DM. Soybean hay. Cut samples at mid-to-full bloom stage and before bottom leaves begin to fall or when pods are approximately50 percent developed. Hay should be field-dried to a moisture content of 10 to 20percent.
(48) Soybean silage. Residue data on silage are optional. Harvest sample whenpods are one-half to fully mature (full pod stage). In the absence of silage data, residuesin forage will be used for silage, with correction for dry matter.
(49) Sugarcane bagasse. Information indicates that sugarcane bagasse is mainlyused for fuel. Residue data will not be needed at this stage, but may be needed at a laterdate.
(50) Sugarcane molasses. Residue data are needed for blackstrap molasses.
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(51) Trefoil forage. Cut sample at 5-10 inch or early bloom stage, atapproximately 30 percent DM. Trefoil hay. Cut at first flower to full bloom. Hay shouldbe field-dried to a moisture content of 10 to 20 percent.
(52) Vetch forage. Cut sample at 6 inch to pre-bloom stage, at approximately 30percent DM. Vetch hay. Cut at early bloom stage to when seeds in the lower half of theplant are approximately 50 percent developed. Hay should be field-dried to a moisturecontent of 10 to 20 percent. Vetch does not include.
(53) Wheat forage. Cut sample at 6-8 inch stage to stem elongation (jointing)stage, at approximately 25 percent DM. Wheat hay. Cut samples at early flower (boot) tosoft dough stage. Hay should be field-dried to a moisture content of 10 to 20 percent.Wheat straw. Cut plant residue (dried stalks or stems with leaves) left after the grain hasbeen harvested (threshed).
(54) Wheat. Includes emmer wheat emmer wheat and triticale. No processingstudy is needed for a specific tolerance on emmer wheat.
(55) Wheat milled byproducts. Use highest value for wheat middlings, bran andshorts.
(n) References. The following references should be consulted for additionalbackground material on this test guideline.
(1) Environmental Protection Agency. Pesticide Re-registration RejectionRate Analysis-Residue Chemistry; Follow-up Guidance for: Generating Storage StabilityData; Submission of Raw Data; Maximum Theoretical Concentration Factors; FlowchartDiagrams. EPA Report No. 737-R-93-001, February 1993.
(2) Environmental Protection Agency. Pesticide Re-registration RejectionRate Analysis-Residue Chemistry; Follow-up Guidance for: Updated Livestock FeedsTables; Aspirated Grain Fractions (Grain Dust); A Tolerance Perspective; CalculatingLivestock Dietary Exposure; Number and Location of Domestic Crop Field Trials. EPAReport No. 737-K-94-001, June 1994.
(3) Environmental Protection Agency. Pesticide Re-registration RejectionRate Analysis-Residue Chemistry. EPA Report No. 738-R-92-001, June 1992.
(4) Environmental Protection Agency. FIFRA Accelerated Reregistration-Phase 3 Technical Guidance. EPA Report No. 540/09-90-078, December 1989.
(5) Environmental Protection Agency. Pesticide Regulation Rejection (PR)Notice, tolerance Enforcement Methods-Independent Laboratory Confirmation byPetitioner, February 7, 1996.
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Appendix X
JMPR MANUAL FOR FAO PANEL MEMBERS
INTRODUCTION
The format and language of JMPR evaluations and reports have evolved over the lifetimeof the CCPR-JMPR system. One aim of this evolution has been to make it easier forreaders to find the information they are seeking expressed in a clear and consistent way.
The purpose of this manual is to assist members of the FAO Panel to preparedocuments for the Meeting in a consistent format. It may also be useful to peoplepreparing submissions for review by the FAO Panel. The manual is not intended to dealwith the evaluation process or to provide guidance on the estimation of maximum residuelevels. Documents prepared in the correct format assist JMPR members to digestinformation quickly, and after the Meeting make it easier for the editor to produce finalcopy for publication.
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CONTENTS
1. GENERAL.........................................................................................................................158
2. FORMAT...........................................................................................................................158
3. PAGE NUMBERING.......................................................................................................158
4. TABLES .............................................................................................................................160
5. DIAGRAMS......................................................................................................................160
6. REFERENCES ..................................................................................................................161
7. A RESIDUE EVALUATION (DRAFT MONOGRAPH)...............................................163
7.1. Explanation.................................................................................................................163
7.2. Draft evaluation.........................................................................................................163
7.3. Table of GAP (Good agricultural practices or Approved uses)...............................166
7.4. Tables of residue data ...............................................................................................167
7.5. Processing studies......................................................................................................171
7.6. National Maximum Residue Limits ..........................................................................172
8. DRAFT APPRAISAL........................................................................................................172
8.1. Recommendations ......................................................................................................173
8.2. Further work or information......................................................................................174
10. DRAFT REPORT, GENERAL ITEMS (SECTIONS 2 AND 3 OF JMPRREPORT) ................................................................................................................175
11. DUTIES OF THE FAO PANEL CHAIRMAN..............................................................175
12. DUTIES OF THE FAO PANEL RAPPORTEUR .........................................................175
13. ACTIONS BEFORE THE MEETING ..........................................................................176
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FORMAT OF A RESIDUE EVALUATION .......................................................................177
IDENTITY SECTION FOR NEW AND PERIODIC REVIEW COMPOUNDS.............179
FORMAT OF A DRAFT APPRAISAL. ..............................................................................180
FORMAT OF A DRAFT REPORT ITEM, NEW COMPOUND .....................................181
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1. General1. General
Please produce documents on a word-processor with a standard program. UseWordPerfect 5.1 or Word 6.0 if possible; failing that, an earlier version of WinWord.
References to key combinations such as (Shift-F8, 1, 9) in the following textrefer to those used in WordPerfect 5.1.
Please bring both floppy disks and hard copy to the Meeting.
It is very helpful if one copy of the draft monograph can be produced single-sidedwith the text 1½- or double-spaced for editing. Tables can be single-spaced.
Try to insert all codes for pagination, font, page numbering, etc. at the start of thedocument and avoid repeating them unless a temporary change is needed. Such codesscattered about in the body of the text can make editing difficult.
Introduce line-numbering (Shift-F8, 1, 5) into all documents for discussion. Theline numbers assist people to find parts of the document to be discussed.
2. Format2. Format
The text of the final report and evaluations will be printed in a 12 cpi (characters perinch) font, so please use this size if you have it.
Left/right margins should be 1 inch (2.5 cm) and top/bottom margins 0.5 inch.Lines should be fully justified, with widow/orphan protection (Shift-F8, 1, 9).
Tabs for general text should be set at half-inch (12.5 mm) intervals. If tabs areneeded in tables they should be re-set so that a single tab, not a series of tabs, separatessections.
The first line of a paragraph immediately following a heading should begin at theleft-hand margin. The first line of subsequent paragraphs should be indented one tab, as inthis manual.
A page header should be introduced on the top left of each page of the documentto show the title of the document, for example: PHORATE Evaluation, or PHORATEReport, or RESIDUES IN FEEDS Report.
3. Page numbering3. Page numbering
Please set page numbering (Shift-F8, 2, 6) to "Top centre". (The document willautomatically begin on page 1. Do not set either a specific "New page number" or "Nopage numbers".
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4. Tables4. Tables
Please insert tables in their intended positions in the text or thereabouts, not at the end ofthe monograph. Although it is customary to collect tables at the end of articles forpublication in journals, different considerations apply to the production of camera-readycopy. It makes editing quicker and easier if tables are in their correct position in the text.
Please always use the WordPerfect or Word Tables program if possible. It is theeasiest way to create tables and makes them much easier to edit. It is an ideal format forsuch tables as lists of recommendations and Annex I, which are likely to be changedseveral times, because lines can be added or deleted easily and quickly without affectingthe structure of the table. See for examples Annex I of the 1995 report and theRECOMMENDATIONS sections of the Evaluations 1995.
Generally, separate items of information should be recorded in separate cells oftables. For example, in tables of recommendations, the Codex Commodity Number andthe Codex commodity description should be in separate cells of the row. It is particularlydesirable that separate lines of tables are in separate rows of cells. WordPerfect will notdivide cells when moving to a new page, so a cell that is several lines deep can causeproblems in tables occupying more than one page.
WordPerfect normally creates tables divided into individual cells with lines roundthem. If you don not want the lines you can delete them, but it makes editing easier ifyou leave them in and add a note asking the editor to delete them. In particular, do notjoin cells vertically (as distinct from deleting lines separating them): this causes thesame problems as cells that are several lines deep.
Always use the portrait (vertical) rather than the landscape (horizontal) layout fortables if possible. Quite wide tables can be accommodated vertically by reducing thetypeface to 15-17 cpi or by using the WordPerfect "Fine" or "Small" attribute (Ctrl-F8, 3or 4). For examples see 1991 Evaluations, Azinphos-methyl Tables 1, 3; Parathion Tables4, 7, 10 etc. Please at all costs keep to the standard margins. Tables which occupy the fullwidth of a page can be very difficult to edit.
Please do not include the caption of a table as a header within the table itself: itforces the same caption to appear on subsequent pages and thus makes it difficult for thereader to find the beginning of a long table.
It is generally better not to construct a table covering several pages as a series ofseparate single-page tables. This usually produces a number of partly-filled pages.
5. Diagrams5. DiagramsThese will usually be hand-drawn or photocopies provided by manufacturers, butWordPerfect accepts diagrams drawn with Windows 3.0 or 3.1. If hand-drawn,WordPerfect can draw accurately-positioned horizontal and vertical lines of any chosenlength, so diagrams will look neater if you connect the items in them by WP lines rather
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than drawing angled lines by hand. For examples see 1991 Evaluations, Cadusafos Figure1 (p. 198); Glufosinate-ammonium Figure 1 (p. 420).
6. References6. References
References to unpublished reports, journals and books should be listed alphabetically inthe form shown in the examples below.
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REFERENCES [bold, centred, caps]
Fischer, R. and Schulze, E.-F. 1983a. The effect of Hoe 02782 OF AT202 (fentinacetate, active ingredient 96.4%) on Salmo gairdneri (Rainbow trout) in a static test.Hoechst Pfl. Fo. Biol., Germany. Rep. OEK 83 001E. Unpublished.
Fischer, R. and Schulze, E.-F. 1983b. The effect of Hoe 29664 OF AT205 (fentinhydroxide, active ingredient 97.0%) on Salmo gairdneri (Rainbow trout) in a static test.Hoechst Pfl. Fo. Biol., Germany. Rep. OEK 83/028E. Unpublished.
Gildemeister, H., Bürkle, W.L. and Sochor, H. 1985. Hoe 029664-14-C. Anaerobic soilmetabolism study with the fungicide triphenyltin hydroxide (TPTH). Hoechst Analyt.Labor., Germany. Rep. (B) 221/85. Unpublished.
MacDougall, D. 1964. Guthion. In: Zweig, G., Analytical Methods for Pesticides, PlantGrowth Regulators and Food Additives, Vol. II, Academic Press, New York, London.
Meagher, W.R., Adams, J.M., Anderson, C.A. and MacDougall, D. 1960. Colorimetricdetermination of Guthion residues in crops. J. Agric. Food Chem. 8, 282-6.
Notes: (1) Inclusive pagination should be shown as, e.g., 282-6 rather than282-286.
(2) Citations in the text should name both of two authors, but only thefirst of three or more. Thus if the first three references above werequoted together in the text the citation should be (Fischer andSchulze, 1983a,b; Gildemeister et al., 1985). Note the form of et al.(italics, with stop after al).
(3) If there are two or more multi-author works with the same firstauthor in the same year, the year should be followed by "a", "b" etc.,even if the co- authors are different, e.g.:
Rogers, E., Tufts, K. and Westberg, G.L. 1989a. Determination of ethylene thiourea incrops. Method MTF-88AM-004. Morse Laboratories, Inc., USA. Unpublished.
Rogers, E., Tufts, K., Normington, S. and Westberg, G.L. 1989b. Determination ofethylene thiourea in meat. Method ETU-89AM-004. Morse Laboratories, Inc., USA.Unpublished.
Rogers, E., Normington, S., 1989c. Determination of ethylene thiourea in tomato.Method ETU-89AM-005. Morse Laboratories, Inc., USA. Unpublished.The above publications should be quoted in the text as: (Rogers, E., et al., 1989a., Rogers, E., et al., 1989b, and Rogers, E., Normington, S.,1989c.)
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7. A residue evaluation (draft monograph)7. A residue evaluation (draft monograph)
The format of an FAO Panel residue evaluation is shown in Annex 1. The use of capitals,centre and side headings, bold and underlining should follow this format.
When a compound is evaluated for the first time, replace the EXPLANATIONsection (Annex 1) by the IDENTITY section (Annex 2). When a periodic reviewcompound is evaluated, add the IDENTITY section after EXPLANATION.
7.1. Explanation7.1. Explanation
Provide a very brief history of the compound in the introductory sentence, for example:"Folpet was first evaluated in 1969 and has been reviewed several times since, mostrecently in 1984, 1986 and 1987....." If a question was raised at the CCPR refer to theSession number and year, e.g. .. “at the 23rd (1991) Session of the CCPR it wassuggested (ALINORM 91/24A, para ...)”
If the compound is being reviewed in the CCPR periodic review programme, statethis in the first paragraph, for example: "Parathion-methyl, originally evaluated by theJMPR in 1965 and re-evaluated for residues several times up to 1984, is included in theCCPR periodic review programme."
Mention briefly previous JMPR requests for further information if relevant to thetopic. Summarize the information available to the Meeting. State that information wassupplied by (list of countries) and the basic manufacturers. Do not include companynames.
For new and periodic review compounds, state explicitly whether information wasor was not provided on critical supporting studies (metabolism, animal transfer,processing, analytical methods, freezer storage stability).
7.2. Draft evaluation7.2. Draft evaluation
Prepare a draft evaluation for the Meeting containing all the sections listed in Annex 1except APPRAISAL, RECOMMENDATIONS and FURTHER WORK ORINFORMATION, which are assembled as a separate draft document (See Section 8,Draft appraisal).
In the top right-hand corner of the first page give the year, the author's name andthe draft number. A reference number and a word-processing filename will be assigned tothe compound at the Meeting. The reference number should then be added after the year(FAO/94/ref no.). Add the extension .EV1 to the filename to show that it is draft 1 of theevaluation. The filename will consist of the pesticide name or an abbreviation of it withnot more than 8 letters (the maximum allowed in a filename). The layout is shown below.
FAO/94/..
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AUTHORFILENAME.EV1
DRAFT 1
Avoid trade names in the description and table of use patterns; give thecomposition and formulation type, e.g. 100 g/kg WP, 200 g/l EC. Use CIPACabbreviations for formulation types (see Appendix III).
Animal metabolism (including farm animal metabolism) studies appear in theMETABOLISM AND ENVIRONMENTAL FATE section. For a new compound animalmetabolism studies should be available to both the FAO Panel and the WHO Group.Metabolism in laboratory animals, normally rats, should be reviewed from the FAO Panelperspective. It should provide information which helps in the interpretation of farmanimal metabolism and transfer studies. This information includes rates and pathways ofexcretion, identity and relative abundance of metabolites, and possible target organs forresidues. Animal metabolism studies are sometimes supplied to the WHO Group only;the FAO Panel reviewer should specifically request these studies for a new compound ora periodic review compound if they have not been provided.
Animal metabolism studies can usefully be introduced with a paragraph which actsas a checklist of the information to be recorded.
Tissue, egg and excreta residues were measured in laying hens (groups of 5, each birdweighing 1.0-1.4 kg) dosed orally for 7 days by capsule with radiolabelled mancozeb([14C]ethylenediamine) equivalent to 3, 14 or 36 ppm mancozeb in the feed (studyreference). The feed intake was 88-96 g/bird/day. Eggs and excreta were collectedthroughout, and birds were slaughtered 24 hours after the final dose for tissuecollection.
Examine the animal metabolism in terms of the requirements for animal transferstudies (see section 3.1.5.1 of the Manual). Draw conclusions from the animal metabolismwhich will assist interpretation of the animal transfer studies. Make statements aboutbioaccumulation and possible target tissues for residues.
A paragraph which acts as a checklist for experimental details can also be used tointroduce plant metabolism studies.
A tomato crop was treated with radiolabelled mancozeb ([14C]ethylenediamine) at 2.7kg ai/ha, on nine occasions at approximately weekly intervals, and ripe tomatoes wereharvested 5 days after the final treatment (study reference).
Draw conclusions from the plant metabolism studies which assist interpretationof the residue trials. State whether the residues are on the surface or within the tissues.Describe the mobility of the residues within the crop and say whether transfer fromfoliage to fruit, root or other edible portion is likely. Draw attention to any plantmetabolite which is not also an animal metabolite.
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Explain the basis for proposed residue definitions under the section 'ResidueDefinition' within METHODS OF RESIDUE ANALYSIS. The explanation wouldnormally take into account metabolism of the compound, practical regulatory analyticalmethods and other matters. The opinion of the WHO Expert Group should be sought onthe toxicological importance of some metabolites. Conclude the section withstatements of the residue definitions.
Definition of the residue (for compliance with MRL): ...................
Definition of the residue (for estimation of dietary intake): ...............................
Tables of residue data should generally be in the same order as commodities inthe Codex Commodity Classification. The general order is fruits, vegetables, grasses,nuts and seeds, herbs and spices, feed commodities. Each commodity type should befurther divided if the amount of information is large. The Codex order should generallybe preserved, for example citrus fruits, pome fruits, stone fruits, berries and other smallfruits, etc.
Where there are many residue tables, it is useful to list them at the beginning ofthe RESIDUES RESULTING FROM SUPERVISED TRIALS section, in numerical order.
Interpretation of the residue data should generally be in the APPRAISAL sectionof the evaluation rather than in RESIDUES RESULTING FROM SUPERVISED TRIALS.The RESIDUES RESULTING FROM SUPERVISED TRIALS section should containdetails which are not readily included in the tables but are still needed to assess thevalidity and relative importance of the results, for example the intervals between sprayapplications, the number of replicate plots, whether samples are replicates from the sameor different plots or merely replicate analyses of the same sample, the size of plots,growing season, method of application, irrigation and, in animal trials and transferstudies, animal weights and ages. The reviewer's judgement is required to decide whichdetails could influence the residues or the validity of the trials.
Include animal transfer studies in the section RESIDUES RESULTING FROMSUPERVISED TRIALS. Animal transfer studies use unlabelled compounds to establishthe relationship between the levels of the residues in the feed and likely residues intissues, milk and eggs.
Animal transfer studies can again be introduced by a paragraph which acts as achecklist of the information.
Groups of 10 laying hens (each bird weighing 1.0-1.3 kg) were fed aged mancozebresidues at nominal levels of 5, 15 and 50 ppm (1×, 3× and 10×) in the diet for 28 days(study reference). Eggs were collected each day for analysis. On day 29 six hens fromeach group were slaughtered for tissue collection. The remaining hens from each group
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were placed on a residue-free diet and slaughtered on days 36 and 43. Birds consumed130 g feed each per day.
7.3. Table of GAP (Good agricultural practices or Approved uses)7.3. Table of GAP (Goodagricultural practices or Approved uses)
Comparison of GAP with conditions in the supervised trials is a necessary part of theevaluation process. The table of GAP should be prepared in such a way that it allows easycomparison with supervised trials conditions. If at all possible fit the table to the normalportrait page rather than changing to landscape (See also Section 4, Tables).
The first column in the table should list the crops, and all uses on each cropshould be brought together. This facilitates evaluation of the residue data. Othercolumns in the table should list countries (in alphabetical order), application (number,rate, spray concentration) and PHI. Note that this is the general case and there is often aneed for further information such as formulation, details of the use pattern (e.g. furrowtreatment, seed treatment), crop growth stage, grazing withdrawal, etc. Listing by countrywas the practice in earlier monographs, but listing by crop is better for residue dataevaluation.
An example is provided below.
Table 2. Registered uses of folpet on vegetables and cereals.
Crop Country Form Application 1 PHI, days
Method Rate kg ai/ha Spray conc,kg ai/hl
Number
Barley France 1.5 21
Beans Greece WP foliar 0.6-1.5 0.1-0.25 3-4 7
Beans Portugal WP foliar 0.13 1-2 7
Beans, green Spain WP foliar 1.6 0.16 21
Brassica vegetables Italy WP foliar 0.35-0.40 10
Lettuce France WP foliar 0.64 21-412
Lettuce Israel3 WP foliar 2.0 weekly 11
1 g: glasshouse use.2 Summer PHI 21 days, winter PHI 41 days.3 proposed registration.
Remarks can be added as footnotes, as in the example.
Suggested abbreviations for footnotes to the GAP table are:
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a:fg:g:gs:Po:pr:st:t:w:
aerial applicationfield and glasshouse useglasshouse use onlygrowth stage restrictionpost-harvest useproposed registrationseed treatmenttable grapes onlywine grapes only
If there are many uses it may be wise to split them into separate tables for fruits,vegetables, etc. If there are very large numbers of uses it may be necessary to establishseparate tables for different groups of fruits, vegetables, etc., arranged according to theCodex Classification. Individual crops within the chosen groupings should be arranged inalphabetical order.
Submissions to the JMPR often include the PHI in the table of national MRLs.The PHI is a part of GAP and should be included with other GAP information.
Use the following units for application rates and spray concentrations; note thatabbreviations are without full stops:
field treatmentgrain treatment, post-harvestfurrow treatmentspace fumigationspray concentration
kg ai/hag ai/tg ai/mg ai/m3
kg ai/hl
7.4. Tables of residue data7.4. Tables of residue data
Express residue concentrations as mg/kg.
Deal with commodities in the order of the "Types" in the Codex Classification ofFoods and Feeds, namely Fruits, Vegetables,..., and within the types in the order of thegroups Citrus fruits, Pome fruits, Stone fruits, etc. A systematic and consistentpresentation of data in a standardized order will make it easier for the reader to findinformation in a large evaluation, and assists Panel members to find the relevant data fordiscussion during the Joint Meeting.
Tables of residues resulting from supervised trials should be carefully prepared insuch a way as to assist evaluations. (See also Section 4, Tables).
The table caption should be clear and comprehensive. It should normally mentionthe compound and the crops or crop groups, and indicate that the residues were found insupervised trials. If all the trials took place in one country or one year or with oneformulation type it is better to put the information in the caption rather than use a columnin the table. See, e.g., 1991 Evaluations, Azinphos-methyl Tables 6, 9a (pp. 17, 19).
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Please always use the portrait, not landscape, format for residue tables. It is nevernecessary to use landscape if the sampling intervals are arranged vertically, and rarelynecessary even if they are arranged horizontally (See also Section 4, Tables). Use the"Header" function in the "Table edit" mode (Alt-F7, 4) to ensure that the table headerappears at the top of each page of a multi-page table.
Space can be saved by using the first column of the table for three categories ofinformation which cannot be confused, as shown below. The year is the year of the trialrather than the year of the report. Include references or study numbers in residue tables.It is important to identify the source of any reported data.
CROPCountry, year
Application Residues Reference
BROCCOLIGermany, 1976 PBH360/77Netherlands, 1980 RL401-90NLCABBAGES, HEADCanada, 1986 8013.86aGermany, 1978 PBJ287/78
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"Application" should normally include the formulation, the number ofapplications, and both the rate of application (kg ai/ha) and spray concentration (kg ai/hl),as shown below.
ApplicationForm No kg ai/ha kg ai/hl
The intervals after the final application at which the residues were found should bearranged in rows or columns to suit the set of trials. If metabolite residues are alsoreported, the table should be arranged so that it is quite clear which metaboliteconcentration relates to which parent concentration. Examples are given below ofpossible arrangements of the residues section of the table.
Residues, mg/kg,after PHI, days.
0 4 7 14 21
Day Residues, mg/kg1
Compound Metabolite0 1.3, 2.2 0.56, 0.854 1.1, 0.43 0.63, 0.317 0.76, 0.68 0.44, 0.1014 0.14, 0.24 <0.05, 0.0721 0.06, <0.05 <0.05, <0.05
1 Underlined residues are from treatments according to GAP
Report individual residues as far as possible. If results are grouped avoid widePHI ranges. If there are a number of values at the same level they can be recorded as<0.05 (7), where there are 7 values of <0.05 mg/kg.
Underline residues resulting from treatments within GAP and double underlinethose which have been selected for estimation of STMR, but wherever such underliningis used its meaning must be explained in a footnote, a note in the table caption, or a notein the introduction to the tables. This is very helpful for people assessing the results,
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particularly when the tables are extensive, and allows other Panel members to see wherethe reviewer has judged data to be within or outside GAP.
Round numbers in tables to a practical level, usually 2 significant figures. Aformulation concentration should be reported as 250 g ai /kg, not 250.00 g ai/kg.Residues should be reported as 0.36 and 4.5 mg/kg, not 0.363 and 4.47 mg/kg.
Near the LOD (limit of determination) rounding to 1 significant figure isrecommended. For example, if the LOD is 0.05 mg/kg, report residue data from 0.05 to0.09 mg/kg to 1 significant figure.
Avoid abbreviations if they make the table difficult to understand. If anabbreviation is unlikely to be familiar to readers and is not in the list of abbreviations atthe beginning of the reports and evaluations, explain its meaning in a footnote.
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Common specialized abbreviations which do not need explanation are:
MRL maximum residue limit (especially Codex Draft MaximumResidue Limit; cf CXL below)
GAP good agricultural practice(s)ADI acceptable daily intakeTMDI theoretical maximum daily intakeLOD limit of determinationCXL Codex Maximum Residue Limit (a Codex Draft Maximum
Residue Limit becomes a CXL after its adoption by theCodex Alimentarius Commission)
STMR supervised trials median residueSTMR-P supervised trials median residue, processed commoditykg ai/ha kilograms active ingredient per hectarekg ai/hl kilograms active ingredient per hectolitremg/kg milligrams per kilogramg ai/t grams active ingredient per tonneg ai/m grams active ingredient per metreg ai/m3 grams active ingredient per cubic metre
Note that the above abbreviations, and those of names of countries andorganizations, are printed without stops (thus also UK, USA, FAO, CCPR) but generalabbreviations in common use have stops (c., e.g., etc., i.e., viz.). Consult the list at thebeginning of recent JMPR Reports and Residue Evaluations for the correct form ofabbreviations. Note the form of et al. (italics, with full stop after al).
Convert non-metric units to metric. Convert lb ai/acre to kg ai/ha, formulationconcentration % to g/kg or g/l, residue concentration ppm to mg/kg, but express feedconcentrations of active ingredients in feeding trials as ppm. This convention is used toavoid confusion between mg/kg feed and mg/kg body weight.
Use Codex commodity descriptions if possible (Codex Classification of Foodsand Animal Feeds in FAO/WHO, 1997).
7.5. Processing studies7.5. Processing studies
Set out tables carefully so that it is absolutely clear which sample is derived from whichin the processing. Indicate the scale of the process by the weight of commodityprocessed. Note any problems with sampling or analysis. Provide a brief description ofthe field treatments in the trial and state the application rate in the study with respect tothe maximum label rate (e.g. 5×label rate).
Some commercial processes are quite complex. It may be useful to provide aflow diagram to explain the process. See 1991 Evaluations, Parathion, Figures 1-5 (pp.556-564).
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A copy of the section on processing studies, including the estimated processingfactors and residues in the edible portion of food commodities, should be sent to reachthe WHO Joint Secretary by the end of August of the current year. See also Section 13,Actions before the Meeting.
7.6. National Maximum Residue Limits7.6. National Maximum Residue Limits
It will usually be necessary to summarize the information in a table. Do not include PHIsin this table.
The normal column headings will be Country, Commodity, MRL. Footnotes or anextra column will be required if countries are using different residue definitions.
8. Draft appraisal 8. Draft appraisal
The APPRAISAL section of the monograph, together with the FURTHER WORK ORINFORMATION and RECOMMENDATIONS, is prepared as a separate document forintensive discussion at the meeting. It contains the logic and a full explanation for eachrecommendation.
In the top right-hand side of the first page give the year, the author's name, theword-processor filename and the draft number as shown below. Add the extension .AP1to the filename to show that it is draft 1 of the appraisal. Add the reference number as inthe draft evaluation. Annex 3 shows the format for a draft appraisal.
FAO/94/AUTHOR
FILENAME. AP1DRAFT 1
Line-numbering of the document assists discussion at the Meeting. Introduceline-numbering to the draft report using the Format function (Shift-F8, 1, 5). Early draftsshould be in 1½ spacing.
Briefly explain the reasons for the review and summarize the informationavailable. The subject order in the appraisal should generally follow the order in theevaluation.
Do not include tables in the text of the appraisal. Side headings should alsogenerally not be used. When an appraisal is extensive and deals with many commodities,crops and animals, it is helpful to underline the commodity name the first time it appearsin each paragraph.
Provide in full the interpretation used to estimate a maximum residue level.Explain extrapolations, comparability and any conditions of use, crop characteristics etc.
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which influence the interpretation. As an example the following paragraph states therelevant use pattern on the crop, the number of trials and country to match the use patternand the residue data selected for estimating STMRs in rank order. The concludingparagraph on this commodity states explicitly the recommended MRL and STMR andincludes the residue expressions according to the relevant residue definitions.
The UK use pattern on strawberries allows thiram application of 1.6 kgai/ha beginning at white bud burst, with repeats at 7-10 day intervals and a PHI of7 days. Seven strawberry trials in Belgium were evaluated against the UK usepattern. The highest thiram residues (median underlined) in each trial within rangeof the UK use pattern were: 1.4, 1.4, 2.1, 2.1, 2.4, 2.8 and 3.1 mg/kg. The highestresidue, 3.1 mg/kg as thiram, is equivalent to 2.0 mg/kg dithiocarbamates as CS2.
The Meeting estimated a maximum residue level of 5 mg/kg fordithiocarbamates (as CS2) in strawberry arising from the use of thiram. TheMeeting estimated an STMR of 2.1 mg/kg for thiram (as thiram) on strawberry.
Examples of other concluding sentences are:
The Meeting agreed to withdraw the recommendations for cherries (1 mg/kg), peaches (3mg/kg) and plums (1 mg/kg).
The Meeting estimated a maximum residue level for sweet corn of 0.1* mg/kg as being apractical limit of determination.
The Meeting estimated a maximum residue level of 1 mg/kg for carrots to replace theprevious recommendation (0.5 mg/kg).
The Meeting agreed to withdraw the previous recommendation for citrus fruits (5mg/kg), to be replaced by recommendations for oranges (1 mg/kg) and mandarins (2mg/kg).
The Meeting agreed to maintain the current recommendation of 0.2 mg/kg for potatoes.
The format of an Appraisal, with RECOMMENDATIONS and FURTHER WORKOR INFORMATION, is shown in Annex 3.
8.1. Recommendations8.1. Recommendations
List commodities with MRL and STMR recommendations alphabetically in theRECOMMENDATIONS Table followed by processed commodities with STMR-Precommendations.
The Recommendations table for periodic review compounds should include allcurrent MRLs. The table will then show whether each MRL is maintained, amended orwithdrawn.
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Any recommendations to withdraw MRLs should be entered in the table ofRecommendations, which will be reproduced in Annex I to the report, and not merelymentioned as a recommendation in the text. A statement such as "the Meetingrecommended the withdrawal of the MRL for pome fruits" is easily missed when Annex Iis being compiled.
8.2. Further work or information8.2. Further work or information
The items listed as required or desirable should be numbered if there is more than one.
Required
All items listed as required should have a year proposed as the due date. Choose 2years from the current Meeting as the due date in the absence of other information, e.g. adefinite commitment by a country or company to provide information by a nominateddate.
Each item listed as required should be tied to a TMRL. If the requiredinformation is not supplied by the due date, the Meeting can then recommend withdrawalof the TMRL.
TMRLs are generally not introduced for new compounds or periodic reviewcompounds. Their use should be kept to a minimum.
Desirable
Information requested as desirable is not vital to the continued existence ofMRLs, but is requested because it may assist in an explanation, support an extrapolationor provide a more complete data base.
9. Draft report
A decision has been made to restrict the length of Section 4 of the JMPR Report onresidue aspects of compounds. An example of the material to be included and the formatof such a report are given in Annex 4. In reports on compounds other than newcompounds the text before the heading RESIDUE AND ANALYTICAL ASPECTS isomitted.
Such a report should be prepared for each compound. The RECOMMENDATIONS andFURTHER WORK OR INFORMATION sections, exactly as described under Draftappraisal, should be attached to the report.
The report should conclude with a sentence such as one of the following:
The residue levels shown in Annex I are recommended for use as MRLs.
The residue levels shown in Annex I are recommended for use as ERLs.
The changes shown in Annex I are recommended.
The withdrawals shown in Annex I are recommended.
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10. Draft report, general items (Sections 2 and 3 of JMPR Report)10. Draft report, generalitems (Sections 2 and 3 of JMPR Report))
In the top right-hand side of the first page give the year, space for the section number(the number [2.XX or 3.XX] will be assigned during the Meeting), the author's name, theword-processor filename and the draft number, as shown below. Create the filenamefrom a key word or words in the title of the report (using up to 8 letters) with theextension RE1 after the decimal point for draft 1 of the report item.
GENERAL REPORTFAO/94/
AUTHORFILENAME.RE1
DRAFT 1
Introduce line-numbering (Shift-F8, 1, 5) into the draft report. The line numbersassist people to find parts of the document to be discussed. Early drafts should be in 1½spacing.
Use the style and language of reports in recent years.
If the report is prepared in response to a recommendation or referral from theCCPR state this in the first paragraph. Use a phrase such as `... at the 23rd (1991)Session of the CCPR ...' or if there is need to refer to a specific paragraph `... at the 23rd(1991) Session of the CCPR (ALINORM 91/24A, para......).....'
11. Duties of the FAO Panel Chairman11. Duties of the FAO Panel Chairman
The Chairman maintains liaison with the WHO Group Chairman on the progress of theMeeting, and together they arrange the schedule for joint sessions. The FAO PanelChairman serves as either Chairman or Vice-Chairman of the Joint Meeting.
The Chairman ensures that all items are given reasonable discussion and tries tobring the Meeting to an agreement. Reasonable progress must be made, and the intentionis to distribute drafts of general report items to the WHO Group by the Friday afternoonof the Joint Meeting and final drafts of most report items by the second Mondayafternoon of the Joint Meeting.
12. Duties of the FAO Panel Rapporteur12. Duties of the FAO Panel Rapporteur
The system has evolved where individual Panel members act as rapporteurs fordiscussion on any documents they have prepared. With the volume of work to be dealtwith it would not be practical to channel all the work through one person.
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The FAO Panel Rapporteur keeps in touch with the WHO Group Rapporteur,ensures that documents are exchanged, and keeps records of the exchanges.
The FAO Panel Rapporteur acts as the channel for typing and copying, keepsrecords of this and ensures that documents are not delayed.
13. Actions before the Meeting13. Actions before the Meeting
A copy of the table of Recommendations should be sent to reach the editor named by theJoint FAO Secretary by the end of August of the current year. If the table is extensive, adisk copy should also be sent.
A copy of the section on processing studies and residues in the edible portion offood commodities and the table of Recommendations should be sent to reach the WHOJoint Secretary by the end of August of the current year. See also Section 7.5,Processing studies.
Prepare a brief list of questions on each compound and points for discussion byPanel members. The list should be available on the first day of the Panel meeting andshould aim to focus attention on any difficult questions which have arisen during thereview.
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ANNEX 1
Format of a residue evaluationFormat of a residue evaluationFAO/94/
AUTHORFILENAME.EV1
DRAFT 1COMPOUND (Codex number) [Bold caps, centred]
EXPLANATION [Bold caps, at left margin][The EXPLANATION section is not included for new compounds.]
IDENTITY [Bold caps, at left margin][The IDENTITY section is included only for new compounds and periodic reviewcompounds. See Annex 2]
METABOLISM AND ENVIRONMENTAL FATE [Bold caps, at left margin]
Animal metabolism [Bold, initial cap only, at left margin]Plant metabolism [Bold, initial cap only, at left margin]Environmental fate in soil [Bold, initial cap only, at left margin]Environmental fate in water/sediment systems [Bold, initial cap only, at left margin]
METHODS OF RESIDUE ANALYSIS [Bold caps, at left margin]
Analytical methods [Bold, initial cap only, at left margin]Stability of pesticide residues in stored analytical samples [Bold, initial cap only, at leftmargin]Residue definition [Bold, initial cap only, at left margin]
USE PATTERN [Bold caps, at left margin]
RESIDUES RESULTING FROM SUPERVISED TRIALS [Bold caps, at left margin]
FATE OF RESIDUES IN STORAGE AND PROCESSING [Bold caps, at left margin]
In storage [Bold, initial cap only, at left margin]In processing [Bold, initial cap only, at left margin]Residues in the edible portion of food commodities [Bold, initial cap only, at left margin]
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RESIDUES IN FOOD IN COMMERCE OR AT CONSUMPTION [Bold caps, at leftmargin]
NATIONAL MAXIMUM RESIDUE LIMITS [Bold caps, at left margin]
APPRAISAL [Bold caps, at left margin]
RECOMMENDATIONS [Bold caps, at left margin]
Definition of the residue:
FURTHER WORK OR INFORMATION [Bold caps, at left margin]
Required (by [year]) [Heading underlined, initial cap only, at left margin]
Desirable [Underlined, initial cap only, at left margin]
REFERENCES [Bold caps, centred]
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ANNEX 2
Identity section for new and periodic review compoundsIdentity section fornew and periodic review compounds
COMPOUND (Codex number) [Bold caps, centred]
IDENTITY [Bold caps, at left margin]
ISO common name:Chemical name
IUPAC: [Indented one Tab]CA:
CAS No:CIPAC No:Synonyms:Structural formula:Molecular formula:Molecular weight:
Physical and chemical properties [Bold, initial cap only, at left margin]
Pure active ingredient [Underlined, initial cap only, at left margin]
Vapour pressure: [Indented one Tab]Melting point:Octanol/water partition coefficient:Solubility:Specific gravity:Hydrolysis:Photolysis:
Technical material [Underlined, initial cap only, at left margin]
Purity: [Indented one Tab]Melting range:Stability:
Formulations [Bold, initial cap only, at left margin]
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ANNEX 3
Format of a draft appraisal Format of a draft appraisal.
FAO/94/AUTHOR
FILENAME.AP1DRAFT 1
COMPOUND (Codex number) [Bold caps, centre]
APPRAISAL [Bold caps, at left margin]Text of the appraisal.
FURTHER WORK OR INFORMATION [Bold caps, at left margin]
Required (by [year]) [Heading underlined, initial cap only, at left margin]
Desirable
RECOMMENDATIONS [Bold caps, at left margin]
An example is shown below.
On the basis of the data from supervised trials the Meeting concluded that the residuelevels listed below are suitable for establishing maximum residue limits and for IEDIassessment.
Definition of the residue for compliance with MRL and for estimation of dietary intake:tebufenozide.
Tebufenozide is a fat-soluble compound.
COMMODITY MRLmg/kg
PHI STMR orSTMR-P
CCN NAME new Current days mg/kg
FP 0009 Pome fruit 1 14 0.16
FB 0269 Grape 0.5 21 0.12
TN 0678 Walnut 0.05 14-21 0.03
Apple pomace, wet 0.4
Apple juice 0.02
Grape pomace, wet 0.36
Wine 0.03
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The withdrawal of an MRL recommendation is shown as a "W" in the Table with afootnote (W: the previous recommendation is withdrawn).
ANNEX 4
Format of a draft report item, new compoundFormat of a draft reportitem, new compound
FAO/94/AUTHOR
FILENAME.RE1DRAFT 1
4. COMPOUND (number) [Bold, at left margin]
Systematic IUPAC name [Centred, but will probably occupy most of line]
Paragraph(s) describing the uses of the compound. [First paragraph starts at left margin;subsequent paragraphs after one Tab]
The compound was considered for the first time by the present Meeting.
RESIDUE AND ANALYTICAL ASPECTS [Bold caps, centred]
Example:
4. METIRAM (186)
RESIDUE AND ANALYTICAL ASPECTS
Residue and analytical aspects of the compound were considered for the first time by thepresent Meeting.
Metiram is a non-systemic fungicide with a very broad spectrum of activity and isregistered for use on cereals, fruits, vegetables, tobacco and ornamental in numerouscountries. It is active against downy mildews, rust fungi and a number of leaf spot fungi.Resistance to metiram has not developed during more than 30 years of use.
The Meeting received extensive information on metabolism, environmental fatein soil, methods of residue analysis, stability of residues in stored analytical samples,approved use patterns, supervised residue trials, animal transfer studies and the fate ofresidues during food processing.
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Metabolism studies on lactating goats, laying hens, apples and potatoes werereviewed. Information was provided to the Meeting on the environmental fate of metiramin soil, including information on hydrolysis and photolysis.
The methods of residue analysis for metiram rely on acid hydrolysis to releaseCS2, which is then measured colorimetrically or by gas chromatography. The methods arethe same as those for the other ethylenebis(dithiocarbamate)s, mancozeb and maneb. TheMeeting agreed that the residue should be defined as a dithiocarbamate residue: TheMRLs refer to total dithiocarbamates, determined as CS2 evolved during acid digestion andexpressed as mg CS2/kg.
Information was provided to the Meeting on the frozen storage stability ofmetiram and ETU on apples, wet and dry apple pomace, apple juice, sauce, baby food,tomatoes, potatoes and sugar beets.
The Meeting received residue data from supervised trials on the followingcommodities:
apples, pears, apricots, cherries, peaches, plums, currants, gooseberries,grapes, strawberries, and bananas;
cabbages, cauliflowers, cucumbers, tomatoes, lettuce, beans, peas,potatoes, celery;
wheat, rape seed, hops, wheat forage, wheat straw.
Animal transfer studies in which lactating dairy cows were dosed with metiramwere reviewed.
Processing studies were available for metiram on apples (to apple puree and applejuice), pears (to pear compote) and grapes (to grape juice, must and wine).
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SUBJECT INDEX
A
Active ingredient (a.i.), 3, 4, 10, 11, 14, 15, 17, 18, 19, 22,35, 38, 65, 67, 69, 75, 118, 139, 141, 143, 145, 146,147, 149, 155
Active ingredient, physical and chemical properties, 4, 12,35, 54
ADI - Acceptable Daily Intake, i, 2, 3, 36, 58, 59, 61, 62,64, 75, 76, 78, 147
Animal feed, 11, 24, 25, 28, 29, 46, 50, 57, 77, 78, 79, 92,93, 95, 96, 109, 110
Animal products, 13, 23, 36, 43, 50, 57Animal transfer study, 4, 24, 25, 45, 50, 141, 142, 157,
158Application method, 14, 19, 70Application rate, 14, 17, 19, 21, 22, 33, 37, 65, 67, 143,
147
B
body weight (b.w.), 25, 75, 76, 147
C
CAC - Codex Alimentarius Commission, 2, 3, 4, 6, 33,61, 73, 75, 76, 77, 78, 79, 84, 87, 147
CCN - Codex Commodity Number, 75, 156CCPR - Codex Committee on Pesticide Residues, v, 2, 3,
6, 7, 8, 13, 16, 17, 28, 39, 48, 51, 59, 62, 66, 71, 75,84, 85, 86, 94, 119, 133, 140, 147, 151
CIPAC - Collaborative International Pesticides AnalyticalCouncil, v, 10, 18, 75, 83, 140, 155
Codex Priority List, 6, 8, 119Commercial product, 6, 22Critical supporting studies, 9, 31, 32, 40, 76, 140CXL - Official Codex Limit, 75, 85, 86, 147
D
Data, requirements, i, 9, 43Data, submissions for evaluation, i, 8, 9, 13, 31, 32, 57,
60Directory of information, 31, 32Dry weight of commodities, 24, 25, 57
E
EDI - Estimated Daily Intake, 20, 27, 62, 63, 75, 77Edible portion of food, 5, 27, 28, 46, 48, 62, 63, 67, 81,
110, 114, 117, 141, 151EMDI - Estimated Maximum Daily Intake, 62, 75EMRL - Extraneous Maximum Residue Limit, 6, 58, 75,
77, 81ERL - Extraneous Residue Limit, 29, 54, 55, 75, 77, 81
F
Fate of residues, adsorption by soil, 12Fate of residues, hydrolysis, 12, 45, 157Fate of residues, in storage and processing, 4, 26, 28, 40Fate of residues, in the environment, 3, 4, 11, 12, 39, 54,
116, 153, 157Fate of residues, in water/sediment system, 11, 12, 39,
116, 153Fate of residues, photolysis, 12, 157Fate of residues, storage stability, 3, 9, 13, 34, 40, 71, 76,
85, 140, 158
G
GAP - Good Agricultural Practice, 2, 9, 14, 15, 18, 19,21, 28, 32, 34, 35, 37, 39, 40, 41, 45, 46, 47, 48, 49,52, 53, 54, 58, 59, 60, 64, 65, 67, 70, 75, 76, 77, 78,81, 85, 117, 142, 143, 145, 147
GAP - Good Agricultural Practice, national, 37, 48, 70GCPF - Global Crop Protection Federation (former
GIFAP), 75Guideline Leveles, 59, 60, 61
I
Identity of pesticides, 4, 11, 39, 80, 141IEDI - International Estimated Daily Intake, 20, 27, 63,
64, 75, 77, 156Iinternational trade, i, 2, 6, 20, 23, 38, 49, 54, 55, 57, 70,
78, 102Indicator molecule, 41, 42ISO - International Standard Organization, 10, 16, 21, 74,
75, 155IUPAC - International Union of Pure and Applied
Chemistry, 10, 74, 75, 76, 155, 157
J
JMPR, i, ii, 1, 3, 4, 6, 7, 8, 9, 10, 13, 14, 15, 20, 23, 24,25, 26, 28, 29, 31, 33, 35, 36, 37, 38, 39, 40, 42, 45,46, 48, 49, 50, 51, 52, 53, 54, 55, 56, 58, 59, 60, 62,63, 64, 66, 67, 69, 70, 75, 76, 77, 78, 79, 80, 81, 82,85, 86, 119, 133, 140, 143, 147, 150
L
Label, 14, 16, 18, 19, 85, 99, 117, 147LOD - Limit of Determination, 5, 11, 13, 29, 39, 44, 58,
59, 63, 66, 75, 78, 80, 98, 146, 147, 149
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M
Metabolism, 3, 4, 5, 9, 11, 12, 24, 25, 26, 33, 34, 36, 39,41, 45, 50, 53, 54, 70, 76, 85, 116, 118, 128, 139, 140,141, 153, 157
Metabolism, in animals, 5, 11, 50, 116, 140, 141, 153Metabolism, in farm animails, 11, 141Metabolism, in plants, 11, 12, 39, 116, 128, 141, 153Monograph, 9, 31, 32, 33, 35, 58, 74, 136, 137, 139, 148MRL - Maximum Residue Limit, i, v, 1, 3, 6, 7, 13, 20,
23, 24, 28, 30, 32, 33, 38, 40, 41, 42, 44, 45, 46, 49,50, 51, 52, 53, 54, 57, 58, 59, 60, 62, 64, 65, 66, 67,70, 71, 75, 76, 77, 78, 80, 81, 84, 85, 86, 87, 102, 141,147, 148, 149, 156
MRL, Codex, i, 3, 6, 8, 46, 57, 62, 70, 73, 78, 87MRL, expression, 24, 57, 58MRL, national, 4, 40
N
National monitoring programme, 5, 29, 39NEDI - National Estimated Daily Intake, 63, 75New compounds, evaluation, 3New compounds, selection, 6
P
Periodic review of pesticides, 3, 4, 8, 9, 10, 26, 31, 39, 40,44, 46, 60, 82, 84, 86, 140, 141, 149, 150, 153, 155
Pesticide residues in, rotational crops, 12Pesticide residues, definition, 23, 28, 29, 32, 33, 37, 39,
40, 41, 42, 43, 44, 45, 46, 58, 66, 71, 76, 79, 141, 148Pesticide residues, total, 12, 23, 41, 42, 43, 44, 59PHI - Pre-harvest interval, 15, 17, 18, 19, 22, 23, 47, 48,
49, 65, 75, 142, 143, 145, 149, 156Portion of commodity to be analysed, 23, 57, 71Processed food, 27, 38, 46, 80Processing factor, 27, 67Processing studies, 27, 33, 38, 70, 147, 151, 158Product monograph, 9
R
RAC - Raw agricultural commodity, 27Residue analysis, 4, 12, 39, 41, 96, 157Residue analytical methods, for enforcement, 12, 13, 41,
42, 44, 78, 80, 141Residue evaluation, appraisal, 156Residue evaluation, format, 153Residue evaluation, identity section, 155Residue evaluation, report, 157Residues, mobility, 12, 36, 141Residues, persistence, 12, 19, 36, 48, 54, 65
S
Sample preparation, 21, 58Sampling, 9, 20, 21, 26, 45, 58, 71, 73, 88, 89, 90, 91, 92,
94, 95, 96, 97, 98, 99, 100, 144, 147
Sampling, cereals, 95Sampling, fruits, 91Sampling, grasses, 93Sampling, processed commodities, 96Sampling, shipping of samples, 99Sampling, storage of samples, 100Sampling, stored commodities, 96Sampling, vegetables, 92, 94SPS - Sanitary and Phytosanitary Measures, 70STMR - Supervised Trials Median Residue, 41, 50, 63,
64, 65, 66, 67, 68, 76, 81, 145, 147, 148, 149, 156Supervised residue trials, i, 3, 4, 7, 12, 13, 20, 21, 24, 28,
32, 33, 34, 35, 36, 37, 38, 40, 41, 46, 47, 48, 54, 58,59, 63, 64, 67, 70, 71, 76, 78, 81, 142, 144, 147, 156,157, 158
T
TMDI - Theoretical Maximum Daily Intake, 62, 63, 147TMRL - Temporary Maximum Residue Limit, 60, 80, 81,
150Total diet study, 5, 28
U
Use Pattern, 3, 4, 8, 14, 15, 16, 17, 31, 33, 37, 39, 49, 63,140, 142, 148, 149, 157
V
Veterinary uses, 26
W
WTO - World Trade Organization, i
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