The 29th Session of the CCPR (1997, ALINORM 97/24A paragraph 99.3) requested the JMPR to give particular consideration to the concerns of developing countries when elaborating criteria for extrapolating residue data to minor crops in the proposed revision of the FAO Manual on the Submission and Evaluation of Residue Data with particular attention to the commodities identified in CX/PR 97/16 Appendix 1 and CX/PR 97/17 Appendix 1, question 4.
The issue was previously considered by the 1989 JMPR (report, Section 2.11) and briefly by the 1996 JMPR (report, Section 2.5) as part of the estimation of group maximum residue levels. The report of the 1996 JMPR formed the basis for Section 5.4.2 of the FAO Manual. The 1996 JMPR also drew attention to the development of minimum data requirements which are under consideration by governments, industry and the Organisation for Economic Cooperation and Development (OECD). Minimum data requirements and situations where extrapolation is valid are closely related.
The 1989 JMPR confirmed that decisions to extrapolate are on a case-by-case basis when adequate relevant information is available. Adequate information would include information on GAP for the relevant crops, a reference to the residue data used to support the original MRL, and an explanation of the logic for the extrapolation.
The FAO Manual provides advice on extrapolations and the nature of the information needed to support an extrapolation.
Section 18.104.22.168 of the Manual states that selective surveys may provide supplementary information which will assist in extrapolations. The approved use pattern of the pesticide on the minor crop should be the same as or similar to that on a major crop for which an MRL is already adequately supported by data. The selective survey should be fully documented and should focus on samples of the minor crop produced under typical commercial conditions where the pesticide is known to have been used.
Section 5.4.2 discusses the estimation of group maximum residue levels and gives examples and limitations. Adequate data for the major crops of a group may be sufficient to estimate maximum residue levels for the whole group.
The Meeting examined the list of pesticides frequently encountered in commodities from developing countries in Appendix 1 of document CX/PR 97/16. Many of the commodities listed, e.g. apples, grapes, oranges, potatoes, are major commodities and extrapolation to major crops is generally not acceptable. Where residues are a problem or potential problem for trade, national governments are invited to submit data for review by the JMPR. A number of the pesticides listed in document CX/PR 97/16 are scheduled for periodic review in the near future and the ideal time to submit data on a pesticide is at the time of its periodic review.
The data submitted to support extrapolation to a minor crop must include the following information.
1. Background information on the reasons for describing the crop as minor, the importance of the use of the pesticide in terms of pests controlled, the extent of its use on the minor crop, and the nature of the problems or potential problems for international trade
2. A description of the cultural practices for the production of the major crop and the approved or registered uses of the pesticide on the major crop from which extrapolation is proposed.
3. A description of the cultural practices for the production of the minor crop, the approved or registered uses of the pesticide on the minor crop, and the reasons for expecting similar residue levels on the minor crop to those on the major crop.
4. Supervised residue trials on the major crop supporting the MRL or reference to the JMPR Evaluations if trials data have already been reviewed by the JMPR.
The data submission should also include the following supporting information where available.
1. Data on supervised trials with approved or registered uses on the minor crop.
2. A copy of the label describing the registered or approved uses and an English translation of the instructions for use.
3. Monitoring data from selective surveys on the minor crop produced under typical commercial conditions where the pesticide is known to have been used.
The Meeting recommended that the CCPR request national governments to provide information on situations where extrapolation of residue data to minor crops is considered feasible at the national level.
The Meeting welcomed the initiative by the CCPR ad hoc Working Group on Problems Relative to Pesticide Residues in Food in Developing Countries and recommended that national governments prepare data submissions for commodities of concern when the specific pesticides are scheduled for review by the JMPR.