4.1 Standardised format of the directory
4.2 Standardised format of the working paper/monograph
4.3 Organization of the submission
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 submitted without benefit of an index/table of contents or even a covering letter. These submissions require a significant amount of work on the part of the FAO Secretariat and Panel members before the data are ready for evaluation.
The increasing workload of the FAO Panel and the detail required in the residue evaluations have led to the development of a procedure aimed at increasing the efficiency of the operation of the FAO Panel through improving the consistency and quality of the data submissions provided.
Manufacturers are requested first to submit a detailed index or directory of information to be provided (by November of the year preceding the scheduled review). The working paper or monograph summarising the results of the trials and the conclusions drawn from them, together with copies of original reports, must be submitted by 28 February of the year of the scheduled review.
The aim of the detailed index or directory is to ensure that an acceptable data package will be available for the consideration of the FAO Panel. The index or directory provides an opportunity for the data submitter to conduct a cursory overview of the data package and identify any outstanding gaps or to omit studies which are obviously not up to current standards. From this index, however, it is not possible for the FAO JMPR Joint Secretary to determine the acceptability of residue data vis-à-vis the use pattern, the availability of critical supporting studies, the monograph, etc.; initially that remains the responsibility 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 facilitates planning for the JMPR and helps ensure an equitable distribution of work among the Panel members. A comprehensive directory of the data provided makes it easier for the reviewer to find the relevant section or study, particularly in a large submission. These directories would provide a permanent record of the data submitted and facilitate access to the information by the Panel member.
The preparation of a draft working paper or monograph is expected to facilitate the evaluation of the data by the reviewer and the overall operation of the Panel. It is not intended as a substitute for the FAO Panel review of the individual study reports. Only those pesticides accompanied by a technical working paper or monograph which provides an evaluation of the information submitted would be accepted in the case of new compounds and those for periodic review.
The detailed reports submitted to the FAO Panel in support of the working paper must be organised in such a way that they are readily accessible to the reviewer. It is preferable to have the technical reports organised according to the standardised format of the directory. The collation of the information according to the different sections and subheadings proposed here might still be accomplished with reports or submissions developed for national regulatory authorities.
A manual for FAO Panel members was published in the Report of the 1994 JMPR A revised version is attached to this document as Appendix X. The purpose of the manual is to assist members of the FAO Panel to prepare documents for the meeting in a consistent format. It may also be useful to those preparing submissions for review.
In order to update the evaluation schedule for the FAO Panel, a detailed directory of the information to be submitted is requested as explained above. The information should be presented (alphabetically according to author) under the following headings and sub-headings as proposed for the Residue Evaluations. It may also be useful to assign the subheadings consecutive numbers within each section.
References in the directory should be in the format currently used in the Residue Evaluations (see Appendix VII). Where possible the reference should include the Volume number of the submission where the study is located. In situations where the volume 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 or Word for Windows 6.0 format on 3.5" diskette. This would allow searching for a particular commodity and provide the references in the correct format for incorporation into the Evaluations.
The standard format for organising the data directory (index) of information to be submitted for evaluation is given in Appendix VII.
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 an overview of the relevant residue data and critical supporting studies submitted to the FAO Panel for estimation of maximum residue levels. This working paper must be supported by the original technical reports. The individual reports must be accurately referenced in the submitted directory.
The working paper, or monograph, should provide an evaluation of the technical data. It should, where appropriate, relate the residue data to the residue definition, analytical methods, GAP information, dose levels in animal studies etc., and clearly demonstrate the basis for a proposed MRL. The sub-sections describing supervised trials should follow the sequence of the Codex Commodity Classification and conclude with an evaluation of the information provided. In the case of submissions provided in support of a new or existing MRL, the evaluation may be limited to a brief discussion of the available residue data and GAP information. In the latter case, new critical supporting studies are valuable information and should be submitted. The re-submission of old studies 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 not necessarily in the format specified here, provided a directory has been enclosed which permits the reviewer ready access to the individual technical reports. There may also be the need for additions to such submissions, for example:
i) commodity descriptions in Codex terms
ii) summaries of good agricultural practices
iii) summaries of residue data from supervised trials.
The data and information required for JMPR evaluation and the formats recommended for preparing the summary information are described in detail in Chapter 3 (Data and Information Required for JMPR Evaluation). The information from the individual studies should be organised according to the suggested subheadings in the directory with an evaluation of the available data in each subsection. Under the various subheadings, trial details relevant to the assessment of the data that might be considered to influence the residues or the validity of the trials should be explained.
The work of the Panel would be facilitated if schematic diagrams of metabolism pathways were also included in electronic form.
Processing studies should be grouped according to the commodity or substrate of interest. It is often advantageous to summarise the data in tabular format. It is important that the information in such tables is set out carefully so that it is absolutely clear which sample is derived from which product in the processing phase. The scale of the processing by the weight of commodity processed should be indicated. The review of each 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 flow diagram to explain the process would be useful.
The information on national MRLs is best summarised in tabular format. The typical column headings include country, commodity and MRL. Footnotes or an extra column will be necessary if countries use different residue definitions or the limits were set on a portion of the commodity which is different from that recommended by the CAC.
The technical reports provided in support of the working paper or monograph should be compiled in separate sections as indicated below.
0. Directory
1. Background Information
2. Metabolism and Environmental Fate
3. Methods of Residue Analysis
4. Use Patterns
5. Residues resulting from Supervised Trials
6. Fate of Residues in Storage and Processing
7. Residues in Food in Commerce or at Consumption
8. National Residue Limits
A table of contents should be included at the beginning of each volume. Each volume should be clearly labelled as per the example below:
Company name
Date
Common name of the active ingredient
Number of the volume and total number of volumes in the submission
Title of the section
It would also be helpful if the cover of each volume could include a list of commodities dealt with in that volume (for residue trials, animal transfer, processing and storage stability) and a list of animals, crops, soil and water (for metabolism).
Example:
Bayer AG
December 1992
Fenthion
Volume 15 of 18Section 5 Residues resulting from supervised trials
Citrus fruits
lemons, oranges, tangelosPome fruits
apples, pears
At present a hard copy of the data is submitted directly to the reviewer, with a copy on optical disk or microfiche provided to the FAO Joint Secretary. The directory should indicate the form in which the copies of reports are provided. The preferred format is the optical disc if the data are available in electronic files. In other cases the microfiche of 15 cm × 10.5 cm sheets which accommodate 14 columns by 7 rows of pages. Further reduction complicates the retrieval of the information.
It would greatly facilitate the work of the Panel members and FAO if the working papers, summaries of GAP and residue data could also be provided on diskette in WordPerfect 5.1. or Word for Windows 6.0 word processing format, and the diagrams of metabolism pathways were prepared applying a ChemWindow3 programme suitable for inclusion of diagrams as a graphic in the document.
