ALINORM 04/27/24  |
| ALINORM 04/27/24 |
JOINT FAO/WHO FOOD STANDARDS PROGRAMME
CODEX ALIMENTARIUS COMMISSION
Twenty-seventh Session
Geneva, Switzerland, 28 June - 03 July 2004
REPORT OF THE THIRTY-SIXTH SESSION OF THE
CODEX COMMITTEE ON PESTICIDE RESIDUES
New Delhi, India, 19 - 24 April 2004
CX 4/40.2 CL 2004/16-PR
May 2004
TO: - Codex Contact Points
- Interested International Organizations
FROM: Secretary,
Codex Alimentarius Commission
Joint FAO/WHO Food Standards Programme
Viale delle Terme di Caracalla,
00100 Rome, Italy
SUBJECT: Distribution of the Report of the Thirty-Sixth Session of the Codex Committee on Pesticide Residues (ALINORM 04/27/24)
The report of the Thirty-sixth Session of the Codex Committee on Pesticide Residues will be considered by the 27th Session of the Codex Alimentarius Commission (Geneva, Switzerland, 28 June - 03 July 2004).
PART A: MATTERS FOR ADOPTION BY THE 27TH SESSION OF THE CODEX ALIMENTARIUS COMMISSION
Member Governments and interested international organizations wishing to comment on the Draft MRLs and Proposed Draft MRLs at Steps 8 and 5/8; are invited to do so in writing, in conformity with the Guide of the Consideration of Standards of the Procedure for the Elaboration of Codex Standards Including Consideration of Any Statements Relating to Economic Impact (Codex Alimentarius Procedural Manual, Thirteenth Edition) to the Secretary, Codex Alimentarius Commission, Viale delle Terme di Caracalla, 00100 Rome, Italy (fax: +39 06 57054593; e-mail, [email protected]), not later than 10 June 2004.
Member Governments and interested international organizations wishing to comment on the proposed revocation (not including that of Codex MRLs replaced by the revised MRLs) are invited to do so in writing to the Secretary, Codex Alimentarius Commission, Viale delle Terme di Caracalla, 00100 Rome, Italy (fax: +39 06 57054593; e-mail, [email protected]), not later than 10 June 2004.
Member Governments and interested international organizations wishing to submit comments including the implications which the Proposed Draft Maximum Residue Limits may have for their economic interest are invited to do so in writing in conformity with the Procedures for the Elaboration of Codex Standards and Related Texts (at Step 5) (Codex Alimentarius Procedural Manual, Thirteenth Edition) to the Secretary, Codex Alimentarius Commission, Viale delle Terme di Caracalla, 00100 Rome, Italy (fax: +39 06 57054593; e-mail, [email protected]), not later than 10 June 2004.
PART B: REQUEST FOR COMMENTS:
Member Governments and interested international organizations are invited to comment on the draft MRLs and proposed draft MRLs as contained in Appendix VI of this report at Steps 6 and 3. Comments should be sent in writing in conformity with the Uniform Procedure for the Elaboration of Codex Standards and Related Texts at Steps 3 and 6 including possible implications of the proposed draft MRLs for their economic interests (Codex Alimentarius Procedural Manual, Thirteenth Edition) preferably by an email to Dr Hans JEURING, Food and Consumer Product Safety Authority, Prinses Beatrixlaan 2, PO Box 19506,2500 CM Den Haag, Fax:+31 70 348 4061,E-mail: [email protected], with a copy to the Secretary, Codex Alimentarius Commission, Viale delle Terme di Caracalla, 00100 Rome, Italy (fax: +39 06 57054593; e-mail: [email protected] ), not later than 1 February 2005.
Member Governments and interested international organizations are invited to comment on the proposed Draft Guidelines on the Use of Mass Spectrometry (MS) for Identification, Confirmation and Qualitative Determination of Residues at Step 3 (see paras 188-189 and Appendix VII). Comments should be sent preferably by an email to Dr Hans JEURING, Food and Consumer Product Safety Authority, Prinses Beatrixlaan 2, PO Box 19506,2500 CM Den Haag, Fax:+31 70 348 4061,E-mail: [email protected], with a copy to the Secretary, Codex Alimentarius Commission, Viale delle Terme di Caracalla, 00100 Rome, Italy (fax: +39 06 57054593; e-mail: [email protected] ), not later than 1 December 2004.
Member Governments and interested international organizations are invited to comment on the proposed Draft Guidelines on the Estimation of Uncertainty of Results at Step 3 (see paras 190-193 and Appendix VIII) and should do so in writing preferably by an email. Comments should be sent to Dr Hans JEURING, Food and Consumer Product Safety Authority, Prinses Beatrixlaan 2, PO Box 19506,2500 CM Den Haag, Fax:+31 70 348 4061,E-mail: [email protected], with a copy to the Secretary, Codex Alimentarius Commission, Viale delle Terme di Caracalla, 00100 Rome, Italy (fax: +39 06 57054593; e-mail: [email protected] ), not later than 1 December 2004.
Member Governments and interested international organizations are invited to comments on the set of criteria for the prioritization process of compounds for evaluation by JMPR (see paras 211 - 219 and Appendix X). Comments should be sent in writing preferably by an email to Dr Hans JEURING, Food and Consumer Product Safety Authority, Prinses Beatrixlaan 2, PO Box 19506,2500 CM Den Haag, Fax:+31 70 348 4061,E-mail: [email protected], with a copy to the Secretary, Codex Alimentarius Commission, Viale delle Terme di Caracalla, 00100 Rome, Italy (fax: +39 06 57054593; e-mail: [email protected] ), not later than 1 December 2004.
While considering the proposed revision of the Codex Classification for Foods and Animal Feeds, the Committee agreed to invite additional comments on the proposals for commodities contained in Appendix IX. Comments should be sent in writing preferably by an email to Dr Hans JEURING, Food and Consumer Product Safety Authority, Prinses Beatrixlaan 2, PO Box 19506,2500 CM Den Haag, Fax:+31 70 348 4061,E-mail: [email protected], with a copy to the Secretary, Codex Alimentarius Commission, Viale delle Terme di Caracalla, 00100 Rome, Italy (fax: +39 06 57054593; e-mail: [email protected] ), not later than 1 October 2004.
Proposals are being requested from countries for pesticides to be added to the Codex Priority List of Pesticides, for subsequent recommendation to the Joint Meeting on Pesticide Residue (JMPR) for evaluation.
PART C: REQUEST FOR INFORMATION AND DATA TO BE SENT TO JOINT FAO/WHO MEETING ON PESTICIDE RESIDUES
Governments and interested international organizations are invited to send inventory of data for pesticides on the agenda of the JMPR. Inventories of information on use patterns or Good Agricultural Practices, residue data, national MRLs, etc. should be sent to Dr Amelia Tejada, Plant Protection Service, AGP, FAO, Viale delle Terme di Caracalla, 00100 Rome, Italy, Fax: +39 06 5705 6347
E-mail: [email protected] well before 30 November of a year before a JMPR meeting where a pesticide of concern is scheduled to be evaluated and, submission of residue data should be well before the end of February of the same year as the JMPR meeting. Toxicological data should be sent to Dr Angelika TRITSCHER, WHO Joint Secretary to JECFA and JMPR, International Programme on Chemical Safety, World Health Organization, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland, Fax: +41 22 791 4848, E-mail: [email protected], not later than one year before the JMPR meeting (see Appendix XI of ALINORM 04/27/24).
Those countries specified under individual compounds in the ALINORM 04/2724 concerning matters related to the FAO Panel of the JMPR (GAP, residue evaluation, etc.) on specific pesticide/commodity(ies) or concerning toxicological matters are invited to send information of data availability and/or toxicological data (for deadlines see the paragraph above).
SUMMARY AND CONCLUSIONS
The summary and conclusions of the 36th Session of the Codex Committee on Pesticide Residues are as follows:
MATTERS FOR APPROVAL BY THE 27TH SESSION OF THE COMMISSION
• Priority List for the establishment of MRLs for certain pesticides (paras 204-206, Appendix XI);
Other Matters of Interest to the Commission
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TABLE OF CONTENTS
Paragraphs
Carbaryl (008) 70 - 72
Dicofol(026)75-76 75-76
Diphenylamine (030) 84
Ethion (034) 85
Malathion(049) 93-94
Dichlorane (083) 111-113
Pirimiphos-methyl (086) 119-120
Chlorpyrifos-methyl (090) 121-125
Acephate (095) 126-128
Carbofuran (096) 129 - 134
Methamidophos (100) 135-137
Phosmet (103) 138-140
Propargit (113) 141-142
Aldicarb (117) 143
Oxamyl (126) 144-146
Diflubenzuron (130) 147
Deltamethrin (135) 148-150
Bendiocarb (137) 151
Carbosulfan (145) 152
Methoprene (147) 153
Tolyfluanide (162) 154-156
Oxydemeton-methyl (166) 157
Terbufos (167) 158-159
Hexaconazole (170) 160--161
Penconazole (182) 162
Fenproximate (193) 163
Haloxyfop (194) 164
Tebufenozid (196) 165
Chlorpropham (201) 166
Spinozad (203) 167-168
Esfenvalerate (204) 169
Flutolanil (205) 170
Imidacloprid (206) 171
Cyprodinil (207) 172-173
Famoxadone (208) 174
Methoxyfenozide (209) 175
WORKSHARING 207
SUBMISSION OF DATA TO SUPPORT SHEDULED REVIEWS 208
EXPANDED CAPACITY OF THE JMPR 209-210
DISCUSSION PAPER ON THE PILOT PROJECT FOR EXAMINATION OF
NATIONAL MRLS AS INTERIM CODEX MRLS FOR SAFER REPLACEMENT
PESTICIDES 220-234
DISCUSSION PAPER ON THE ESTABLISHMENT OF MRLS FOR PROCESSED
OR READY-TO-EAT FOODS 259-262
List of Appendices
Pages
Appendix I List of Participants 30
Appendix II Draft and Revised Draft Maximum Residue Limits for Pesticides (Advanced to Step 8 of the Codex procedure) 49
Appendix III Proposed Draft and Proposed Draft Revised Maximum Residue Limits for Pesticides (advanced at Steps 5/8 of the Codex procedure) 56
appendix IV Proposed Draft Maximum Residue Limits for Pesticides (Advanced at
Step 5 of the Codex Procedure) 57
Appendix V Codex Maximum Residue Limits for Pesticides Recommended for Revocation 61
Appendix VI Draft and revised draft maximum residue limits for pesticides (Returned to Step 6 and 3 of the Codex Procedure) 68
Appendix VII Proposed Draft Guidelines on the Use of Mass Spectrometry (MS) for Identification, Confirmation and Quantitative Determination of Residues at Step 3 of the Codex Procedure 72
Appendix VIII Proposed Draft Guidelines on Estimation of Uncertainty of Results (At Step 3 of the Codex Procedure) 77
Appendix IX Proposals to Include of New Commodities in the Codex Classification 83
Appendix X Proposed Revised Criteria for Prioritization Process 90
Appendix XI Priority List of Chemicals Scheduled for Evaluation and Re-Evaluation by JMPR 94
Appendix XII Draft and Revised Draft Maximum Residue Limits for Pesticides (Retained at Step 7 and 4) 99
LIST OF ABBREVIATIONS
(Used in this Report)
CAC Codex Alimentarius Commission
CCFAC Codex Committee on Food Additives and Contaminants
CCGP Codex Committee on General Principles
CCMAS Codex Committee on Methods of Analysis and Sampling
CCNFSDU Codex Committee on Nutrition and Foods for Special Dietary Uses
CCPR Codex Committee on Pesticide Residues
CCRVDF Codex Committee on Residues of Veterinary Drugs in Foods
CLI CropLife International
CI Consumers International
EC European Community
FAO Food and Agricultural Organization of the United Nations
JECFA Joint FAO/WHO Expert Committee on Food Additives
JMPR Joint FAO/WHO Meeting on Pesticide Residues
SPS Agreement Agreement on the Application of Sanitary and Phytosanitary Measures
WHO World Health Organization
WTO World Trade Organization
acute RfD acute Reference Dose
ADI Acceptable Daily Intake
CXL Codex Maximum Residue Limit for Pesticide
DIE Daily Intake Estimate
GAP Good Agricultural Practice in the Use of Pesticides
EMRL Extraneous Maximum Residue Limit
IEDI International Estimated Daily Intake
IESTI International Estimated of Short-Term Intake
MRL Maximum Residue Limit
NOEL No Observed Adverse Effect Level
PHI Pre-harvest Interval
PTDI Provisional Tolerable Daily Intake
STMR Supervised Trials Median Residue
TMDI Theoretical Maximum Daily Intake
INTRODUCTION
1. The Codex Committee on Pesticide Residues (CCPR) held its 36th Session in New Delhi, India, from 19 to 24 April 2004 at the kind invitation of the government of India. Dr H.J. Jeuring of the Food and Consumer Product Safety Authority of The Netherlands chaired the Session. The Session was attended by 38 Member countries, 1 Member Organization and 13 international organizations. The list of participants is attached as Appendix I to this Report.
2. Welcoming addresses were presented by Mrs Rita Teaotia, Joint Secretary, Ministry of Health and Family Welfare, and Chairperson, National Codex Committee, Government of India; Dr S.P. Agarwal, DGHS, Government of India; Dr Mangala Rai, Secretary, Department of Agricultural Research and Education and DG, ICAR, Government of India; Mr J.V.R. Prasada Rao, Secretary (Health), Ministry of Health and Family Welfare, Government of India, and Dr R.K. Mahajan, ADG (PFA), National Codex Contact Point, India.
3. These addresses and presentations highlighted the various international initiatives in managing risks associated with the use of pesticides, and the importance of effective pesticide regulation in order to manage pests, safeguard consumer health and protect the environment. The meeting was informed that the increasing adoption of Integrated Pest Management systems in India, and the greater use of biological control agents had resulted in a significant reduction in pesticides use and that recent legislation had established MRLs for 121 pesticides. Several of the addresses also emphasized the important role of Codex, particularly the CCPR, in establishing international pesticide residue standards to ensure safe food and facilitate trade, and the Committee was congratulated for recognising the special characteristics of spice production in developing countries in it’s current work on the establishment of MRLs for spices.
ADOPTION OF THE AGENDA (AGENDA ITEM 1)
4. The Committee adopted the provisional Agenda as contained in CX/PR 04/1.
5. The Delegation of the European Community presented CRD 11 on the division of competence between the European Community and its Member States according to Rule II, Paragraph 5 of the Rules of Procedure of the Codex Alimentarius Commission.
APPOINTMENT OF RAPPORTEURS (AGENDA ITEM 2)
6. Dr D. Lunn (New Zealand) and Dr Y. Yamada (Japan) were appointed as rapporteurs.
MATTERS REFERRED TO THE COMMITTEE BY THE CODEX ALIMENTARIUS COMMISSION AND/OR OTHER CODEX COMMITTEES (AGENDA ITEM 3)3
7. The Committee noted that matters arising from the 26th Session of the Codex Alimentarius Commission (CAC), the 53rd Session of the Executive Committee, the 25th Session of the Committee on Methods of Analysis and Sampling (CCMAS), the 36th Session of the Codex Committee on Food Additives and Contaminants (CCFAC) and the FAO/WHO were presented for information purposes or would be discussed in more detail under the relevant Agenda Items.
8. Matters of special interest to the Committee included the Commission decision to meet annually, at least for the next two years; the new requirement for project document for new work; and progress in the adoption of MRLs and Guidelines.
9. The Committee also noted that the 25th CCMAS amended the text proposed by the 35th CCPR on single laboratory validated methods of analysis to make it more general and send it through the CCGP to the Commission for adoption; the CCFAC’s interest in the revision of the Codex Classification of foods and animal feeds and the highlights of the recent FAO/WHO/OIE expert workshops on antimicrobial resistance.
REPORT ON GENERAL CONSIDERATIONS BY THE 2003 JOINT FAO/WHO MEETING ON PESTICIDE RESIDUES (AGENDA ITEM 4)4
10. In recent years, JMPR included in their evaluation a classification of the pesticides based on the ‘WHO recommended classification of pesticides by hazard’ (IPCS 2002). The 2003 Meeting noted that classification is related to occupational hazard not dietary intake risks and decided to discontinue listing this information.
11. The Delegation of the EC noted that they agree with the JMPR on the guiding criteria and principles for the classification, but that it is not of the opinion that confusion might occur between the classification and the performance of acute dietary risk. Therefore the Delegation of the EC regrets the decision by the JMPR to no longer include this classification.
12. The 2001 and the 2002 Meetings indicated that haematological effects may occur after single exposure to a chemical and therefore such effects may form the basis for an acute reference dose (RfD). The 2003 Meeting set acute RfDs for three compounds, famoxadone, methoxyfenozide and tebufenozide, on the basis of haematotoxic effects occurring after repeated exposure. The mechanism causing these effects is unknown, and hence it is unclear if these effects can also occur after single exposure. The Meeting acknowledged that the acute RfD, for these three compounds or based on conservative assumptions and the assessment could be refined in the future.
13. For such a refinement, general guidance on appropriate single dose studies addressing haematological endpoints needs to be developed. In this context the Meeting recommended to establishment of a working group to develop such further guidance.
14. The Committee was informed that the working groups final draft guidance document on the setting of acute RfD will be discussed at the 2004 JMPR and published in the report of that meeting.
15. The Committee was updated on the FAO/WHO consultative process on the review of the provision of scientific advice. In this process background papers were posted on the Internet for public comments (through an electronic forum) and a workshop was convened by the FAO and WHO to discuss means to improve the provision of scientific advice by FAO and WHO to Codex and Member States. The Committee was advised that the final report of the workshop is available on the Internet and that CRD 35 included the executive summary and the recommendations from this workshop.
16. The Committee was also informed that a Joint FAO/WHO Expert Consultation was planned (but not yet funded) to further consider issues and recommendations that require more development.
17. The Delegation of Japan expressed their hope that the project will be timely completed.
18. The Committee was informed that the 2002 JMPR had considered the options for estimating maximum residue levels for spices based on monitoring data (2002 JMPR Report) and provided guidance on the format for reporting such data and the 2003 JMPR gave further consideration to possible options for estimating maximum residue levels when there is insufficient monitoring data and prepared guidelines for conducting selective surveys to generate pesticide residue.
19. The EC considers it important that the analytical quality of the data is ensured.
20. The Committee was informed that in response to a question of the 35th CCPR on the expression of MRLs for fat-soluble compound in milk in relation to the LOQs, the 2003 JMPR considered the issue and decided that whether or not an MRL for a fat soluble compound in milk should have the suffix “F” depends on: (i) the logPow, (ii) the solubility in fatty animal tissues, and (iii) the distribution between the fat and non-fat fractions of the milk, where available. The 2003 JMPR further clarified that when the suffix “F” is appended, milk fat should be analyzed while without the suffix “F” whole milk should be analyzed. To apply an MRL for milk with the suffix “F” to milk products, the MRL for milk is multiplied by 25 and the resultant value applies to the fat extracted from the milk products.
21. The Delegation of the EC questioned the appropriateness of multiplying the MRL for milk by 25 for the application to milk products when the MRL is at or below the LOQ. The Representative of JMPR noted that the use of “F” outdated its usefulness and currently more sensitive analytical methods are available than before and indicated that further consideration would be necessary.
22. The Committee was informed that this issue would be considered again by the 2004 JMPR.
23. The FAO Joint Secretariat to JMPR advised the Committee that JMPR has refined its extimation of residues and MRLs for processed commodities to remove the double rounding-up associated with examination of the MRL and processing factor. The revised process now involves multiplying the highest RAC residue found in supervised trials by the calculated processing factor to derive the MRL for the processed food. The Committee was informed that a JMPR policy to estimate maximum residue levels only when concentration of residue is expected in processing and for processed commodities for which codex commodity code exist. The EC expressed its reservation regarding the general application of the MRL for a RAC to processed commodities in the case of a processing factor less than 1.
24. The Committee was informed that JMPR has agreed to adopt automated spreadsheet applications developed by RIVM/SIR6, for the calculation of dietary intake with the spreadsheets being used to calculate IEDIs and IESTIs using the formulae described in Section 3 of 2003 Report. The spreadsheet applications will be made available on the following address: http://www.who.int/foodsafety/publication/chem/regional_diets and will be updated when necessary.
25. The Committee was informed of a number of initiatives taken by JMPR to improve the estimation of dietary intakes.
• The 35th Session of the CCPR (ALINORM 03/24A) requested the JMPR to consider the probabilistic aspects in the point estimates, when the results exceed the acute RfD. In response, the 2003 JMPR agreed in principle to adopt a tiered approach to estimating short-term dietary intake, in which the second tier could be probabilistic modelling. However it also recognized the lack of consumption data and the lack of an available model validated at the international level, which hamper the development of such a second tier. The 2003 JMPR welcomed the initiative of the CCPR in deciding to establish a Working Group on this subject. The Meeting noted that a probabilistic model useful for JMPR purposes is under development in The Netherlands (RIKILT, Institute of Food Safety) and agreed that it would consider this model when available.
• The JMPR took note of the prepublication IUPAC report on short-term dietary risk assessment7 and on the basis of the evidence presented, it agreed to use a new default variability factor of 3 in the calculation of residue levels in high-residue units used in point estimates of short-term intake.
• In the situation that the IESTI exceeds the acute RfD, the Meeting agreed to indicate in the section on Dietary Risk Assessment ways in which those parameters used in the dietary risk assessments which are based on conservative assumptions might be refined.
• The JMPR suggested further immediate refinements of the dietary intake by: improving the accuracy of consumption figures for long-term exposure by introducing the proposed 13 sub-regional diets; increased availability of large portion sizes and unit weights for the calculation of short-term exposure, especially those from developing countries; evaluation of typical commercial processing to investigate whether it would be possible to derive default processing factors and/or extrapolate processing data; refinement of generic and commodity-specific variability factors as used in the short-term intake calculations; elaboration of procedures for probabilistic modelling at the international level.
26. The Committee noted that the current JMPR procedures for estimating the short-term dietary intake of pesticide residues rely on the deterministic procedures proposed by the FAO/WHO Consultation in 19978. After considering the discussion paper prepared by the Delegation of The Netherlands for the 35th Session of the CCPR and the IUPAC report9 that summarized and analysed the available data on residue level variability from unit to unit for a number of pesticides over a range of crops the JMPR agreed to adopt a default variability factor of 3 for the estimation of residue levels in high-residue units in the IESTI calculations where unit weights exceed 25 g A variability factor is not used in IESTI calculations where unit weights are below 25 g. However JMPR has confirmed that the current practice will continue of using specific unit variability factors in preference to the default value where the supporting data are available, valid and sufficient.
27. The Committee noted that JMPR based its decision to use a new general default variability factor of 3 on a pre-publication version of the paper which has been published in a peer-reviewed journal in the beginning of March 2004 (CRD 7), and considers this decision to be a risk assessment decision, not a risk management one.. In further explanation for this decision, The Committee was advised that the FAO/WHO consultation held in Geneva 10-14 February 1997 refined the concept of the variability factor to be the residue in the 97.5th percentile unit divided by the mean residue for the lot and that it was crucial to determine the residue value reflecting the 97.5th percentile unit with sufficient confidence. In CRD 7, a statistically sound method is described to achieve this. The JMPR member further indicated that JMPR had revised all the assessments conducted since 1999 for commodity-compound combinations for which the acute RfD had been exceeded. The results are in Chapter 3 of the JMPR 2003 Report. Based on the use of the variability factor of 3, about 30% of the calculated intakes for children were now below the acute RfD. The EC expressed their reservation on variability factor of 3, pending internal evaluation in the EC in view of a late availability of document.
28. The Committee was informed that in response to the request of the last session of the Committee to consider data requirements for environmental fate studies, JMPR has reviewed their data requirements, and the revised set of environmental fate studies required for elucidation is summarized under Sec 2.11 of the 2003 JMPR report.
29. The Committee was advised that the purpose of the pilot project is to investigate the feasibility of using national and regional evaluations to expedite JMPR evaluations and that the main objectives of the worksharing project were to:
• Make better use of available resources
• Increase the transparency of the JMPR evaluation process
• Facilitate the international acceptance of JMPR evaluations by governments
• Facilitate submissions of dossiers by industry
The Delegation of Australia proposed to include an additional bullet to read: “Increase the output of the JMPR evaluation process”.
30. The 35th CCPR had selected trifloxystrobin as compound for this pilot project and it will be evaluated at the 2004 JMPR. Australia, Canada, the EU and the USA have provided their evaluations and identified their evaluator and Japan also has expressed interest. The manufacturer has also provided all original data.
31. For residue reviews, worksharing will include studies or information on identity, physical and chemical properties, metabolism, environmental fate in soil and water-sediment systems, stability of pesticides, analytical methodology and residue definition will be considered. For toxicological reviews all data evaluations will be considered. Currently the FAO- and WHO-appointed experts are reviewing the data and preparing an evaluation for the 2004 JMPR. National/International evaluations are compared and the differences noted. If there are differences in the evaluations, the evaluator will use the original data from the manufacturer and proposes a conclusion to the JMPR.
32. The Committee noted that the practice and experience of this pilot project on worksharing will be discussed at the 2004 JMPR, and an evaluation report summarizing the experience will be prepared after the meeting, for consideration by this Committee in 2005.
33. The Committee was informed that the use of national evaluations is already common practice at JMPR WHO Panel, the outcome of this project will facilitate and formalize this approach.
34. The FAO Joint Secretary advised the Committee that JMPR had already been using the recommendations of the York meeting and the “Zoning Report” whenever possible, but that the JMPR would need further information before their full utilization on some of the recommendations.
35. Recognizing that practical experience would be necessary to see how the recommendations could be implemented, JMPR had agreed to test the practical applicability of the principles with one pesticide in 2004 and has requested FAO to initiate the process and to identify a compound suitable for the pilot project.
36. The FAO Joint Secretary advised the Committee that the JMPR continues to receive supplementary data and information from the sponsors without an indication of the specific purpose for its provision, and that JMPR has re-emphasized that the submitter must explain clearly why the data or information was submitted, with reference to JMPR or CCPR Reports. JMPR considered that this should be a pre-condition for scheduling the evaluation of the submitted material and should be used by the FAO Joint Secretary in presenting the rationale for the evaluation.
37. The 2003 JMPR reconfirmed that the evaluation of the results of additional metabolism studies, and of supervised trials revealing information on the proportions of the parent compound and significant metabolites can only be carried out at the time of a periodic review when all relevant information is available and taken into consideration in deciding on the definition of the residue.
38. When the intention is to change a CXL the request should be addressed to the CCPR; other matters should be addressed to the FAO Joint Secretary to the JMPR
GEMS/FOODS PROGRESS REPORT ON DIETARY INTAKES (Agenda Item 5 )10
39. The Committee recalled that at its 31st session WHO presented its efforts to develop more representative diets using a cluster analysis approach based on FAO Food Balance Sheet data. The Committee welcomed this approach and was informed of the work progress at the 35th session. Using the cluster analysis approach 13 Consumption Cluster Diets were produced; however, major data gaps were encountered. Meanwhile average Food Balance Sheet data for the period 1997-2001 have recently become available to GEMS/Food and it was decided to use this new information as basis for developing new Consumption Cluster Diets. Presently a list of missing country and commodity data is compiled.
40. The WHO Representative informed the Committee that the five GEMS/Food Regional Diets have been updated, and that minor changes had been made to correct small computational errors and to clarify the food codes. The revisions are not believed to significantly alter previous exposure assessments. The Committee noted that copies of the revised GEMS/Food Regional Diets were available on request from the WHO and have been published on the WHO Food Safety website.
41. The Committee was informed that FAO and WHO have agreed to add two additional experts to JMPR starting in 2004: one member will have particular expertise in food consumption data; the other being an expert in food processing practices who would also evaluate data.
42. At the request of the Committee at the 35th session, WHO performed a full acute intake assessment of carbofuran (96) in light of intake concerns.
43. The results calculated using the new variability factor of 3 as introduced by the 2003 JMPR for general population and children age 6, show that except for the consumption of oranges, sweet, sour by children, none of the IESTIs exceeded the acute RfD for general population and children ages 6 and below. The results calculated using the previously applied variability factors show that the IESTIs for children consuming banana, cantaloupe, cucumber and oranges, sweet, sour exceeded the acute RfD.
44. The Delegation of India expressed the view that the large portion size used in the calculation did not reflect the actual consumption, especially in developing countries. The Delegation of the Republic of Korea pointed out that the data provided in the GEMS/FOOD regional diets did not reflect its national data for several commodities. India and Republic of Korea expressed their willingness to send their data.
45. The Representative of WHO invited member countries to provide relevant data to GEMS/Foods in order to improve the current Food Regional Diets.
DIETARY EXPOSURE IN RELATION TO MRL SETTING: DISCUSSION PAPER ON THE ADOPTION OF PROBABILISTIC METHODOLOGY FOR THE PURPOSE OF THE CODEX MRL SETTING (Agenda Item 6)11
46. The Committee recalled that at its 35th session, while considering the discussion paper on proposals for improved methodology for point estimates of acute intake of pesticide residues, it requested a Working Group to prepare a paper considering the adoption of probabilistic methodology for the purpose of Codex MRL setting; and that paper should include worked examples of probabilistic calculations for some compounds for which compound-commodity combinations exceed the Acute RfD in international point estimates using the same parameters (field trial data, consumption data, influence of processing and variability) as those, which were the basis of the JMPR point estimates. The Working Group was also asked to discuss and propose parameters to be used in probabilistic calculations at the international level.
47. The Delegation of the Netherlands introduced the document and indicated that probabilistic intake assessment was a powerful tool for refining of chronic and acute dietary intake assessments. It facilitated cumulative intake assessment and the combined acute exposure assessment of the pesticide in more than one crop; however some limitations still existed at the international level due to the lack of data especially food consumption data.
48. The Delegation pointed out that it was important for risk managers to make a choice on the approach selected for making decisions on the acceptability of MRLs and that it was necessary to select a type of calculation and to decide on the cut-off points such as the percentile level and on the use of other parameters such as the variability factors and whether to use consumption data from “total population” or “consumers only”. The Delegation indicated that new software was developed and made available on the internet; however a short specialized training was necessary to use it properly. It was pointed out that after training the process of probabilistic intake calculations was not so time-consuming and that new consumption data from various countries were now available and might be used for exposure calculations in the future.
49. Several delegations, while generally supporting the concept of probabilistic intake calculations noted that there was still the need to solve several fundamental problems such as: to clarify whether and when “total population” or “consumers only” consumption value should be used as a parameter; that further guidance on the minimum data quality and quantity should be provided; that risk management considerations should take into account the severity of toxicological consequences; that more discussion on the use of variability factors was necessary as this might exaggerate exposure; and that the use of 99.9 percentile for different population groups in relation to acute toxicity required more clarification while the use of this percentile might not be justified sometimes due to the small data base, so that it could be seen as the target for the future. It was also indicated that other models existed for probabilistic dietary intake assessment and that these model should be compared against each other. Several delegations indicated that free availability of models are also important.
50. The Committee noted that some delegations consider that the use of field trials data lead to on overestimation of the exposure, and therefore they apply a lower cut-off level in the probabilistic intake assessment.
51. The WHO Representative informed the Committee of a WHO workshop on intake assessment planned for November 2004. This workshop is part of the ‘Project to Update the Principles and Methods for Risk Assessment of Chemicals in Food’. The WHO Representative recommended that the Committee formulates questions regarding probabilistic intake assessment that could be addressed in this workshop.
52. The Observer of CropLife International, while referring to its written comments in CRD 8, supported the recommendation to use the 99.9 percentile acceptability threshold versus 99.99 percentile and to use the whole population exposure versus consumers only as the basis for the exposure assessment.
53. The Observer of Consumers International indicated that a “consumers only” approach should be used when estimating the intake of residues for a given commodity and the total population approach should be used when estimating the intake of residues in a variety of foods per day and that the definition of “rarely eaten” foods was not clear enough and that approach proposed in the discussion documents could underestimate the risk for consumers. The Observer also was of the view that an approach should be developed to take into account exposures resulting from the presence of a combination of substances with the same toxic effect (e.g. cholinesterase inhibitors such as organophosphorus compounds and carbamates).
54. The Chairperson noted that enforcement authorities sometimes faced practical difficulties in deciding on the acceptance of consignments for commodities where the use of probabilistic intake calculations on a total population basis and the 99.9th percentile, could lead to the acceptance of MRLs where a point calculation of the actual residue detected suggested the acute RfD may be exceeded. The Delegation of Australia noted that in such cases uncertainty factors and the severity of risk should be taken into account when deciding on the acceptability of low probability that the acute RfD is exceeded.
55. Some delegations were of the view that scientific basis for probabilistic intake calculations should be improved and that there was a need to ask FAO/WHO to provide assistance in this regard.
56. Noting the above mentioned WHO Workshop on intake assessment, the Committee decided to establish an Ad Hoc Working Group12 to formulate questions for the above workshop.
57. The Chairperson of the Working Group Dr Kloet introduced the Report of the Ad Hoc Working Group presented in CRD 25 and presented eight questions developed by the Working Group.
58. It was proposed to put an additional question regarding possible problem for the enforcement (see para above), however the Committee was of the view that the issue as phrased in meeting was more relevant for risk managers and therefore did not agree on its inclusion. However, the Committee agreed to come back to the question on the possible enforcement at the next Session and.
59. When considering these questions, the Committee noted that reference in questions related to probabilistic intake assessment rather than probabilistic risk assessment. The Committee deleted the seventh question regarding the need for training and agreed that the following questions to be forwarded to FAO/WHO Workshop on intake assessment:
• Advice should be provided on the circumstances under which a “total population approach” versus “consumers only approach” should be used in the probabilistic modelling of acute exposure to pesticide residues. What is meant by the term “total population” e.g. all consumers or all of a sub-population of consumers e.g. children <6 years? What sub-populations should be considered? Is a “total population approach” sufficiently protective of the consumer for those commodities that are eaten by a low percentage of the population, by a high percentage of the population but only occasionally e.g. the chance of recording a consumption day is low, or by vulnerable populations such as children e.g. for compounds with developmental neurotoxicological effects?
• Advice is required on how the following should be considered in deciding on the ‘cut off’ percentile for risk management in the probabilistic acute exposure distribution e.g. where a deterministic exposure and the specified upper percentile in a probabilistic exposure assessment exceed the acute RfD, what is the appropriate way to express the risk in relation to the magnitude of exceedances?
(i) How should the quality and quantity of the input data and the associated scientific uncertainty including the magnitude and frequency of the risk be expressed?
(ii) Can the severity of the toxicological end-point (e.g. teratogenic versus cholinesterase inhibition) be expressed and how? It is possible to express this risk from a risk management perspective?
(iii) How can the inherent over-estimates of exposure, that would be included in probabilistic dietary exposure assessments at the international level, be quantified? i.e. those resulting from the use of supervised trials residues data rather than monitoring data and those resulting from the intake value from one country with the highest consumption.
• Can precise statements on the variability of data used in probabilistic exposure assessment be made? How can uncertainty be taken into account and specified/presented in terms of specific statements on risk assessments such as those currently used by JMPR?
• How should outputs from probabilistic assessments, including the magnitude and frequency of risk, be reported to ensure the transparency of output?
• How should the information on the quantity and quality of data, the scientific uncertainty and the severity of the toxicological end-point be used by the risk manager to determine the appropriate upper percentile cut-off (e.g. 95, 99, 99.9 or 99.99th percentile)?
• A number of methods exist to allow the decompositing of residues data from field trials to give residues expressed in a form appropriate for acute consumer exposure assessments i.e. as single servings of commodities - a surrogate for the use of variability factors. Which of these methods should be used and how should the outputs be expressed?
• What is the minimum level of reliable data required (including food consumption data) for international probabilistic modelling of acute consumer exposure to support the setting of Codex MRLs? Can guidelines be developed? This issue also needs to be addressed as part of the “output” from probabilistic models.
• The CCPR noted that a number of models for probabilistic intake assessment were available. How should these models be validated and certified as ‘fit for the purpose’ of risk assessment appropriate for JMPR and risk management in CCPR?
• Is there further information that can be provided from risk assessors which would support risk management decision-making based on probabilistic intake assessments at an international level?
DRAFT AND PROPOSED DRAFT MAXIMUM RESIDUE LIMITS FOR PESTICIDES IN FOODS AND FEEDS AT STEPS 7 AND 4 (Agenda Item 7)13
GENERAL REMARKS
60. The Chairman noted that a number of Delegations had expressed opposition to the progression of MRLs where intake concerns had been identified by JMPR and informed the Committee that such MRLs should not be advanced beyond Step 6 until the dietary intake concerns had been addressed.
61. He also informed the Committee that a full list of CXLs and MRLs, for which acute dietary intake concerns had been noted by JMPR, would be available for the next session so that these could be considered for deletion or withdrawal.
62. In responding to the concern expressed by the Delegation of Australia about the elaboration of MRLs for processed commodities where residue concentration did not occur, the Chairman indicated that depending on the outcome of the discussions under Agenda Item 14, it may be possible to consider taking action on these CXLs at the next session.
63. The Committee reaffirmed that where JMPR had confirmed an existing CXL, the confirmed MRL should be progressed through the Steps as a new MRL as the decision of JMPR was based on new data sets and that there was a need to comment on the JMPR recommendation.
64. The Committee agreed to include a footnote in the Appendix for revocations that current MRLs should be revoked only if new MRLs are adopted, where applicable.
65. The Committee noted the written comments from the Delegation of the European Community that within the EC MRLs were derived using a statistical method, possibly leading to different MRLs to those proposed by JMPR from the same data set and that their comments on the MRLs proposed by the 2003 JMPR were preliminary, since the full evaluations were not yet available.
66. The meeting also noted the comments from Consumers International that for organophosphate and related compounds for which no developmental neurotoxicity studies had been evaluated, dietary intake risks to children could not be properly assessed.
67. It was noted that residue definitions on omethoate and carbendazim should be updated.
68. The Secretariat informed the Committee that the web version of updated MRS would be available after next Session of the Commission.
CAPTAN (007)
69. The Committee decided to return the MRLs to Step 6 awaiting toxicological evaluations and new intake calculations by the 2004 JMPR.
CARBARYL (008)
70. The Delegation of Australia expressed their reservation on MRLs for stone fruits and grapes for acute dietary intake concerns. The Delegation of the EC considered the database for some commodities to be insufficient, and expressed acute intake concerns for citrus commodities. The Delegation of Japan noted that the code numbers for some of the commodities still needed to be developed. The Delegation of Thailand requested the retention of the existing CXL for peppers in view of new information on chili peppers which would be provided to the JMPR.
71. The Committee decided to advance the MRLs for almond hulls; asparagus; beetroot; carrot; egg plant; kidney of cattle, goats, pigs & sheep; liver of cattle, goats, pigs & sheep; maize fodder; maize forage; maize oil; crude; meat (from mammals other than marine mammals), milks; olive oil, virgin; olives; peppers sweet; rice bran, unprocessed; rice hulls; rice straw and fodder, dry; rice polished; sorghum forage (green); sorghum forage (dry); soya bean (dry); soya bean fodder; soya bean forage (green); soya bean hulls; soya bean oil, crude; sunflower forage; sunflower seed; sunflower seed oil, crude; sweet corn (corn-on-the-cob); sweet corn cannery waste; sweet potato; tomato; tomato paste; tomato juice; three nuts; turnip, garden; wheat; wheat bran, unprocessed; wheat flour; wheat germ; wheat straw and fodder, dry to Step 8.
72. The Committee decided to return the MRLs of cherries; citrus fruits; citrus juice; citrus pulp, Dry; dried grapes (currants, raisins and sultanas); grape juice; grape pomace, dry; grapes; stone fruits to Step 6. The Committee decided to withdraw the CXLs for all commodities recommended by the 2002 JMPR for withdrawal except one for apple. In addition, the Committee decided to delete the CXLs for rice and sweet corn (kernels) and to retain for 4 years under the Periodic Review Procedure the CXL for peppers (except peppers, sweet), awaiting new information from Thailand.
2,4-D (020)
73. Noting the information provided on the GAP for 2,4-D on citrus fruits, the Committee decided to advance the MRLs for citrus fruits to Step 8.
DIAZINON (022)
74. The Committee decided to return the MRL for cabbages, head to Step 6, awaiting the evaluation of new information from the USA and Australia. The Committee also decided to advance the remaining draft MRLs to Step 8.
DICOFOL (026)
75. The Delegations of India and Morocco informed the Committee that monitoring and field data to support a lower MRL for tea (green, black), can be submitted.
76. The Committee decided to maintain the existing CXL awaiting future evaluations by The JMPR of these new data.
DIMETHOATE (027)
77. The Committee noted written comments of the Delegation of Australia, European Community and USA which opposed the advancement of the MRLs beyond Step6 for commodities with of acute and chronic intake concerns.
78. The Committee noted that the use on grapes, plums/prunes, pome fruits, sorghum and onion bulb would no longer be supported. The Committee was informed that the deletion of the MRLs for these commodities would result in a chronic intake estimate below the ADI for the European diet.
79. The Delegation of Chile expressed its concern with the deletion of these MRLs as dimethoate was commonly used on commodities of great importance in international trade. The Delegation proposed to review the definition in order to take into account omethoate.
80. The Committee noted that the residue definition for dimethoate and that for the calculation of dietary intake dimethoate was considered with omethoate.The FAO Joint Secretary indicated that the residue definition could be reviewed only in the framework of the periodic review of this compound.
81. The Committee agreed to consider the deletion of the the CXLs for apple, grapes, onion bulb, plum (including prunes), pear and sorghum and withdrawal of the draft MRLs for grapes, plums (including prunes) and pome fruit at its next session.
82. The Committee agreed to advance all proposed draft MRLs to Step 5 and returned draft MRLs for barley; grapes; peas (pods and succulent = immature seeds); plums (including prunes); pome fruits; sugar beet leaves or tops; tomato; turip, greens; and turnip garden.
83. The Committee decided to withdraw the draft MRLs Brussels sprouts; cauliflower; lettuce, head; which would be replaced by new proposed draft MRLs; and wheat wheat straw and fodder, dry.
DIPHENYLAMINE (030)
84. The Committee decided to advance the MRLs for cattle milk and pear to Step 8.
ETHION (034)
85. The Committee agreed to delete the CXL for citrus fruits, because the use of ethion would no longer be supported.
FENITROTHION (037)
86. The Committee noted that the 2003 JMPR had recommended withdrawal of the CXLs for meat; milks; rice bran; unprocessed, rice polished; wheat bran, processed; wheat flour, wheat whole meal and white bread.
87. The Committee decided to withdraw the CXL for white bread.
88. The Committee decided to retain the other CXLs recommended for withdrawal for 4 years under the Periodic Review Program as there was support these MRLs.
89. The Committee decided to advance the MRL for cereal grains and wheat bran unprocessed to Step 5. The Committee was informed that data would be available for pome fruits, stone fruits, grapes, tomatoes and soya beans for evaluation at a later date.
FOLPET (041)
90. The Committee decided to return all draft MRLs to Step 6 awaiting review by the 2004 JMPR.
LINDANE (048)
91. The Committee decided to withdraw the CXL for carrot, rape seed, sugar beet and sugar beet leaves or tops.
92. The Committee decided to advance all other MRLs to Step 5/8.
MALATHION (049)
93. The Committee decided to retain the MRLs for commodities who also can be used as animal feed at Step 6 awaiting the review by JMPR of animal feeding studies. The Committee decided to advance the MRLs for asparagus; beans, except broad bean and soya bean; blueberries; cucumber; mustard greens; onion; bulb; spring onion; sweet corn (corn on the cob); tomato juice and turnip greens to Step 8.
94. The Committee decided to retain the current CXL for apple; broccoli; cabbages, head; cereal grains; citrus fruits and grapes awaiting the review of new residue data by the 2004 JMPR.
OMETHOATE (055)
95. The Committee decided to withdraw all draft MRLs because this compound was no longer be supported. The Delegation of the EC indicated that the residue definition for omethoate should include dimethoate (see also para 78).
PARATHION-METHYL (059)
96. The Committee noted that animal transfer studies were not available and decided to return the animal feed and associated commodities: alfalfa fodder; alfalfa fodder (green); bean forage (green); cotton seed; cotton seed oil, crude; cotton seed oil, edible; hay or fodder (dry) of grasses; maize; maize flour; maize oil, crude; maize oil, edible; pea hay or pea fodder; pea vines (green); rape seed; rape seed oil, crude; rape seed oil, edible; sugar beet leaves or tops; wheat; wheat bran, unprocessed; wheat flour and wheat straw and fodder dry to Step 6 awaiting the evaluation of the JMPR.
97. The Committee decided to advance the MRLs for apple; cabbage, head; dried grapes (=currants raisins and sultanas); grapes; peach and peas (dry) to step 8 and the MRL for nectarine to step 5/8.
PIPERONYL BUTOXIDE (062)
98. The Committee noted that the Commission, in 2003 had returned all MRLs to Step 6 due to the concerns about the use pattern. Following an explanation from the Delegation of Australia on the GAP for this compound, the Committee decided to advance all MRLs to Step 8.
99. The Committee decided to request the Commission to reinstate the former CXL of wheat at 10 mg/kg (PoP), if the draft MRL for cereal grains is not adopted at Step 8 (see also para 63) given that the decision to revoke the CXL was taken contrary to the proposal of the CCPR.
PYRETHRINS (063)
100. The Committee decided to advance the MRL for cereal grains to Step 5/8.
THIABENDAZOLE (065)
101. The Delegation of Morocco provided with the preliminary data (CRD 20) and informed the Committee that data on citrus to support a higher MRL will become available this year and will be submitted to the JMPR. The Delegation of USA advised the Committee that the GAP supporting the MRL for mushrooms had been changed in the United States.
102. The Committee decided to return the MRL for citrus fruits and mushrooms to Step 6 awaiting the submission of additional data from Morocco and the USA and to delete the MRLs for melons, except watermelons, and strawberry, as these uses were no longer supported.
103. The Committee requested the JMPR to perform acute intake assessment taking into account the Acute RfD of 0.1 mg/kg bw established by the 2002 JECFA.
104. The Committee was informed that data relating to the acute reference dose would be provided for evaluation by the 2005 JMPR.
CARBENDAZIM (072)
105. The Committee decided to advance the MRLs for asparagus; cherries; common beans pod and/or immature seads); mango; peanut; peanut fodder; pepper, chili; soya bean (dry); squash, summer; sugar beet and sugar beet leaves or tops to Step 5 and returned the remaining MRLs to Step 6 awaiting the establishment of an acute RfD by JMPR in 2005.
DISULFOTON (074)
106. The Committee noted the acute intake concerns had not been resolved even with the use of probabilistic methods.
107. The Committee was informed that the probabilistic assessment did not result in exceedance of exceed the acute RfD for individual commodities although the combined intake from all commodities exceeded the acute RfD. The Committee decided to return the MRLs of broccoli; cabbages, head; cauliflower; lettuce head and lettuce leaf to Step 6 awaiting further refinements in the acute dietary intake probabilistic assessment methodology.
108. The Committee decided to delete the CXLs of potato and radish, Japanese as these were no longer supported.
AMITROLE (079)
109. The Committee noted that the Commission, in 2003 returned all MRLs to Step 6 because of concerns about the methods of analysis.
110. The Committee considered that the analytical methods reported by JMPR were acceptable and advanced all MRLs to Step 8.
DICHLORAN (083)
111. The Committee decided to advance the MRLs for grapes; nectarine and peach to Step 5/8 and to withdraw the existing CXLs for lettuce, head; plums (including prunes); strawberries and tomato as recommended by the JMPR.
112. The Committee was informed that new data on lettuce; plums; strawberries and tomatoes will become available by the end of 2004.
DODINE (084)
113. The Committee decided to advance the MRLs for cherries; nectarine; peach and pome fruits to Step 5.
114. The Committee noted that the CXLs for grapes and strawberries will be considered for deletion next year.
FENAMIPHOS (085)
115. The Committee decided to return the MRLs for peppers; tomato and watermelon to Step 6 because of acute intake concerns and to advance the remaining MRLs to Step 8.
116. The Committee agreed to consider at its next session the deletion of the CXLs for grapes, pineapple and carrot because of acute intake concerns.
PIRIMIPHOS-METHYL (086)
117. The Committee decided to retain the CXLs of meat and eggs for 4 years under the periodic review procedure as the relevant data, including storage stability data, had been submitted to JMPR.
118. The Committee decided to consider the withdrawal of all other existing CXLs at the next session. The Committee agreed to advance the MRLs of cereal grains, milks and wheat bran, unprocessed to Step 5.
CHLORPYRIFOS-METHYL (090)
119. The Committee decided to return all proposals for draft MRLs for barley; oats and rice to Step 6 awaiting review by JMPR.
120. The Delegation Republic of Korea informed the Committee of their chronic dietary intake concerns with the rice MRL and the Committee requested the Delegation Republic of Korea to submit their intake calculations to JMPR.
METHOMYL (094)
121. The Committee decided to advance the draft MRLs to Step 5 for alfalfa fodder; alfalfa forage (green); barley; bean fodder; beans, except broad bean and soya bean; brassica vegetables; celery; citrus pulp, dry; fruiting vegetables, cucurbits; grapes; leafy vegetables; pea vines (green); soya bean forage (green); wheat; wheat bran, unprocessed; wheat flour and wheat germ.
122. The Committee decided to return the proposals for the draft MRLs for apple and pear to Step 6 because of acute intake concerns.
123. The Committee decided to advance the draft MRLs to Step 8 for cotton seed, hulls; cotton seed, meal; rape seed forage; soya bean hulls; soya bean meal; beans (dry); common bean (pods and/or immature seeds); cotton seed; cotton seed oil, edible; edible offal (mammalian); eggs; maize; maize forage; maize oil, edible; meat (from mammals other than marine mammals); milks; nectarine; oats; peach; plums (including prunes); potato; poultry meat; poultry, edible offal of ; rape seed; soya bean fodder; soya bean oil, crude; soya bean oil, refined; straw, fodder (dry) and hay of cereal grains and other grass-like plants.
124. The Committee decided to retain the CXLs for mint hay and peppers for 4 years under the Periodic Review procedure as new data had already been submitted to JMPR.
125. The Committee decided to recommend the revocation of CXLs as recommended by the 2001 JMPR for barley straw and fodder; kale; maize fodder; spinach and also to consider revocation of the CXLs for sweet corn and tomato next year because of acute intake concerns.
ACEPHATE (095)
126. The Committee decided to advance the draft MRLs to Step 5 for artichoke, globe; beans, except broad bean and soya bean; edible offal (mammalian); eggs; flowerhead brassicas; mandarins; meat (from mammals other than marine mammals);milks; nectarine; peach; peppers; pome fruits; poultry meat; poultry, edible offal of and soya bean (dry).
127. The Committee decided to recommend the revocation of CXLs as recommended by the 2003 JMPR at its next session for alfalfa forage (green); cabbages, head; cattle fat; cotton seed; lettuce, head; pig fat; potato; sugar beet; sugar beet leaves or tops; tomato and tree tomato.
128. The Committee decided to retain the CXLs for broccoli and cauliflower until the MRL for flowerhead brassicas reaches Step 8 and to retain the CXLs for cattle meat and pig meat until the MRL for meat (from mammals other than marine mammals) reaches Step 8.
CARBOFURAN (096)
129. The Committee noted that the EC had established an acute RfD ten times lower than that established by JMPR, and the EC was invited to submit their data to JMPR.
130. The Committee decided to advance to Step 5 the draft MRLs for maize; maize forage; potato; sugar beet; sugar beet leaves or tops and also to return to Step 6 the draft MRLs for cantaloupe; cucumber; mandarin; oranges, sweet, sour; squash, summer; sweet corn (corn-on-the-cob) for acute intake concerns.
131. The Committee decided to advance the draft MRLs for cottonseed; rape seed; rice straw and fodder, dry and rice, husked to Step 8.
132. The Committee decided to recommend the revocation of CXLs as recommended by the 1997 JMPR for maize fodder and oilseed.
133. The Committee also requested that the MRL data base for carbofuran should also indicate the source of the MRL, either carbosulfan or carbofuran.
134. The Delegation of India informed the Committee that it would submit data to support a review of the existing CXL for sugar cane.
METHAMIDOPHOS (100)
135. The Committee decided to withdraw the MRLs for peach (1 mg/kg); pome fruits (0.5 mg/kg) and tomato (1 mg/kg) as these had been replaced by newer limits recommended by the 2003 JMPR.
136. The Committee decided to advance all remaining MRLs to Step 5. The Committee agreed to consider at its next session the withdrawal of the CXLs for alfalfa forage (green); cattle fat; cauliflower; goat fat; lettuce head; peppers, chili; peppers, sweet; pig fat; sheep, fat and tree tomato, as recommended by the 2003 JMPR.
137. The Committee agreed to ask JMPR for clarification of cucumber proposal and to reconsider the cucumber CXL at the next session.
PHOSMET (103)
138. The Committee decided to return MRLs for all commodities except tree nuts to Step 6 for because of acute intake concerns and to advance the MRL for tree nuts to Step 8.
139. The Committee was informed that the EC was likely to establish a lower Acute RfD than recently established by the JMPR. The EC agreed that once their evaluation was completed, they would send to JMPR data on how their acute RfD had been derived.
140. The Committee therefore decided to return MRLs for all commodities except tree nuts to Step 6 because of acute intake concerns and to advance the MRL for tree nuts to Step 8.
PROPARGITE (113)
141. The Committee decided to withdraw the CXLs for alfalfa fodder; alfalfa forage (green); apple pomace (dry); common beans (pods and/or immature seeds); cranberry; cucumber; fig; maize fodder; maize forage; mint hay; peanut fodder; peanut forage; sorghum; sorghum forage (green); sorghum straw and fodder dry. Although withdrawal was recommended by the 2002 JMPR for beans (dry); pears; potato; strawberry and walnuts, the Committee decided to retain these CXLs for four years under the Periodic Review Procedure.
142. The Committee decided to advance all the remaining MRLs to Step 8. The Delegation of the EC expressed a reservation for the advancement of the MRL for grapes and grape juice because of intake concern for children.
ALDICARB (117)
143. The Committee decided to return the MRLs for banana and potato to Step 6 because of acute intake concerns.
OXAMYL (126)
144. The Committee decided to withdraw the CXLs for banana; beans, except broad bean and soya bean; celery; coffee beans; maize; onion, bulb, pineapple; soya bean (dry); squash (summer); sugar cane; and watermelon.
145. The Committee agreed to advance the MRLs for carrot, edible offal of cattle, goats, horses, pigs and sheep; eggs; meat (from mammals other then marine mammals), milks; peanut; peanut fodder; poultry meat and poultry, Edible offal of, to Step 8. The Committee furthermore decided to return the MRLs for citrus fruits; cucumber; melons except watermelon, and peppers to Step 6 because of acute intake problems.
146. The Committee agreed with the proposal of the Delegation of Netherlands to add a footnote to indicate that no residues are to expected in meat.
DIFLUBENZURON (130)
147. The Committee decided to delete the CXLs for Brussels sprouts; cabbages, head; cotton seed; plums (including prunes); soya bean (dry) and tomato. The Committee decided to advance the MRLs for citrus fruits; edible offal (mammalian); meat (from mammals other than marine mammals); milks; mushrooms; pome fruits; poultry meat; rice and rice straw and fodder, dry to Step 8.
DELTAMETHRIN (135)
148. The Committee decided to delete the existing CXLs for artichoke, globe; banana; cacao beans; coffee beans; edible offal (mammalian); fig; fruiting vegetables other than cucurbits; hops, dry; kiwifruit; legume animal feeds; melons, except watermelon; oilseed, except peanut; peanut; pineapple; straw and fodder (dry) of cereal grains and tree tomato.
149. The Committee noted that while the 2003 JMPR had not indicated any acute dietary intake concern for leafy vegetables, this conclusion was based on the use of a variability factor of 3. As Delegations had not had sufficient time to examine this intake calculation, the Committee decided to return the MRL for leafy vegetables to Step 6.
150. The Committee decided to advance all remaining MRLs, except for leafy vegetables, to Step 8.
BENDIOCARB (137)
151. The Committee decided to recommend the deletion of all CXLs, recalling that this compound is no longer supported.
CARBOSULFAN (145)
152. The Committee decided to return the MRLs for citrus pulp, dry ; mandarin; and oranges (sweet, sour) to Step 6 because they are associated with the relevant carbofuran MRLs (see para xx). The Committee decided to advance all other MRLs to Step 5, noting that while all these MRLs were at the limit of detection, the omission of Steps 6 and 7 should not be done because the full evaluation was not yet available.
METHOPRENE (147)
153. The Committee was informed that the CXL for peanuts had been revoked by the CAC in 2003 but that there was now some support for the use of this commodity. The Secretariat advised the Committee that since the CXL had been revoked by the Commission, a new MRL proposal would need to be introduced into the system.
TOLYLFLUANID (162)
154. The Committee decided to withdraw the CXL for gherkin.
155. The Committee decided to advance the MRL for lettuce, head at 15mg/kg to Step 5, and delete the earlier proposal at 0.2 mg/kg.
156. The Committee decided to advance all other MRLs to Step 8.
OXYDEMETON-METHYL (166)
157. The Committee decided to return all MRLs to Step 6, awaiting the JMPR 2004 evaluation.
TERBUFOS (167)
158. The Chairman informed the Committee that the 2003 JMPR has established an acute RfD but did not perform an acute dietary intake calculation, as no STMRs HRs had been estimated.
159. The Committee noted that this compound was scheduled for Period Review in 2005.
HEXACONAZOLE (170)
160. The Committee noted that there was no longer support for this compound at the Codex level, however it still would be used in some countries.
161. The Committee decided to delete all existing CXLs.
PENCONAZOLE (182)
162. The Committee recalled that the compound was no longer supported at the international level. However, as the compound has not yet been scheduled for period re-evaluation, the Committee decided to postpone consideration of this compound.
FENPYROXIMATE (193)
163. The Committee decided to return the MRLs to Step 6 awaiting the establishment of an acute RfD and acute intake calculations by the 2004 JMPR.
HALOXYFOP (194)
164. The Committee decided to maintain the MRLs for alfalfa forage (green); cattle kidney; cattle liver; cattle meat; cattle milk; fodder beet leaves or tops and sugar beet leaves or tops at Step 4 and the remaining MRLs at Step 7, awaiting the establishment of an acute RfD by the JMPR.
TEBUFENOZIDE (196)
165. The Committee decided to advance the MRLs for edible offal (mammalian); meat (from mammals other than marine mammals) and milks to step 5/8 and to advance all other MRLs to Step 8, noting that the MRLs for cattle commodities could now be withdrawn.
CHLORPROPHAM (201)
166. Noting that this compound was tentatively scheduled for toxicological evaluation by the JMPR 2005, the Committee decided to return the MRL for potato to Step 6 because of acute intake concerns. As potatoes are a feeding stuff for animals, the Committee also decided to return the MRLs for cattle meat, cattle milk and cattle, edible offal of, to Step 6.
SPINOSAD (203)
167. The Committee decided to advance MRLs for brassica vegetables and leafy vegetables to step 8.
168. Recalling earlier discussions on the question of the expression of milk MRLs for partially fat soluble pesticides, the Committee decided to return the MRL for milk to Step 6 and to request the JMPR to further consider how MRLs should be expressed for milk/milkfat.
ESFENVALERATE (204)
169. The Committee decided to advance MRLs for eggs; poultry meat, poultry edible offal of; rapeseed and wheat straw and fodder, dry to Step 8. Noting that esfenvalerate and fenvalerate have the same residue definition, and that higher fenvalerate CXLs exist for cotton seed; tomato and wheat, the Committee decided to return the MRLs for these commodities to Step 6 until fenvalerate is phased out.
FLUTOLANIL (205)
170. The Committee decided to advance all MRLs to Step 8.
IMIDACLOPRID (206)
171. The Committee decided to advance all MRLs to Step 8.
CYPRODINIL (207)
172. The Committee decided to advance all MRLs to Step 5.
173. The Delegation of Republic of Korea expressed its concern in relation to MRL for strawberries and indicated that their MRL was much lower.
FAMOXADONE (208)
174. The Committee decided to advance all MRLs to Step 5.
METHOXYFENOZIDE (209)
175. The Committee decided to advance all MRLs to Step 5 and agreed that the MRL for spinach should not be advanced beyond Step 6 unless the acute intake concern for children had been resolved.
DISCUSSION PAPER ON THE RISK ANALYSIS POLICIES USED BY THE CODEX COMMITTEE IN ESTABLISHING MRLs FOR PESTICIDES (Agenda Item 8)14
176. The Chairperson introduced the paper prepared at the request of the last session of the Committee and recalled that the Commission had adopted the Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius and had asked relevant Codex Committees develop or complete specific guidelines on risk analysis in their respective areas. The Chairperson highlighted the main aspects of the Proposed Draft Risk Analysis Principles addressing the application of risk analysis principles by JMPR and the Committee on Pesticide Residues and noted that risk management policy had not been included at this stage, but would need to be addressed in the further development of the document.
177. The Delegation of Denmark asked whether that the request for a full safety evaluation (paragraph k) took into account the proposals for establishment of interim MRLs. The Chairperson noted that the document described the current procedures, that the development of interim MRLs was being tested as a pilot project, and changes could be made as required in the further elaboration of the principles.
178. The Delegation of the EC while agreeing to most of the text in the document expressed the view that paragraph l) should be less specific about acute exposure calculations and leave other possibilities open. The Delegation of Australia proposed to amend the sections relating to regional diets (l and x) to make them less prescriptive.
179. The Committee agreed that the reference to “other legitimate factors” should be completed with a reference to the Statements of Principles Concerning the Role of Science in the Codex Decision-Making Process and the Extent to which Other Factors Are Taken into Account.
180. The Delegation of Japan, noted that the Committee had taken several decisions relevant to risk management, that appeared in various working documents and previous reports, and that all these decisions should be compiled in one single document, and proposed several amendments to the text. The Delegation also pointed out that the reference to “safety assessment” should be clarified and that the document should be consistent with the draft risk analysis principles recently finalized by the Committee on Food Additives and Contaminants.
181. The Observer from Consumers International expressed the view that substantial changes should be introduced to current practices in order to ensure conformity with the Working Principles for Risk Analysis adopted by the Commission and to improve the transparency of the process. In particular, the Observer noted that the separation between risk assessment and risk management should be respected and the Committee should carry out the risk management tasks that were currently undertaken by JMPR, such as proposing MRLs and establishing risk assessment policy.
182. The Committee noted that the development of the proposed Draft Principals was in reply to a specific request of the Commission and therefore a project document was not required to justify this new work.
183. The Committee agreed to initiate the development of Proposed Risk Analysis Principles for circulation at Step 3 for consideration by the next session, subject to approval as new work by the Commission. The Committee agreed that the Chairperson with assistance of the Delegation of Japan would redraft the Proposed Draft Principles on the basis of the current document, taking into account the written comments and the discussion of the current session, and containing current CCPR risk management policies.
MATTERS RELATED TO METHODS OF ANALYSIS (Agenda Item 9)15
184. The Committee recalled that its last session had agreed to undertake new work on 1) Proposed Draft Guidelines on the Use of Mass Spectrometry, to be prepared by the FAO/IAEA Joint Training and Reference Center for Food and Pesticide Control and 2) Proposed Draft Guidelines on the Estimation of Uncertainty of Results, to be prepared by the representative of FAO/IAEA. These proposals were subsequently approved as new work by the 26th Session of the Commission.
185. The Committee noted that document CX/PR 04/7 Estimation of Uncertainty of Measurements and Confirmation of Results presented the conclusions of the Consultants’ Meeting convened by the Joint FAO/IAEA Division (Vienna, 22-26 March 2004) in order to provide recommendations on the issues under consideration in the CCPR and to develop the above mentioned guidelines. Due to the short time elapsed since the Consultation, it had not been possible to circulate the Proposed Draft Guidelines for comments at Step 3.
186. The Committee noted that the Consultants’ Meeting had recommended incorporating both Proposed Draft Guidelines into the recently revised Guidelines on Good Laboratory Practice in Residue Analysis.
187. The Chair of the ad hoc Working Group on Methods of Analysis, Dr Piet Van Zoonen (Netherlands) introduced the report of the Working Group (CRD 5) and highlighted its main discussions and recommendations, as follows.
(A) PROPOSED DRAFT GUIDELINES ON THE USE OF MASS SPECTROMETRY (MS) FOR IDENTIFICATION, CONFIRMATION AND QUALITATIVE DETERMINATION OF RESIDUES AT STEP 4
188. The Committee agreed with the changes proposed by the Working Group to the working document as follows: some additional text was included under the derivatisation section; the reference to packed columns was deleted from Table 6; the reference to the ions in Figure 2 was clarified; provisions on reporting of results were clarified; and the reference section was expanded to include other relevant papers. It was further agreed that the document presented in Appendix I of CRD 5 should ultimately replace paragraphs 4.7 to 4.9 of the Guidelines on Good Practice in Pesticide Residue Analysis.
189. The Committee agreed to circulate the Proposed Draft Amendment to the Guidelines on Good Practice in Pesticide Residue Analysis as amended at the present session, for comments at Step 3 (see Appendix VII).
(B) PROPOSED DRAFT GUIDELINES ON THE ESTIMATION OF UNCERTAINTY OF RESULTS AT STEP 4
190. The Committee noted that consideration of measurement uncertainty was relatively recent and that although there is general consensus about the estimation of uncertainty, there are widely different views and practices among members concerning the use of measurement uncertainty in compliance testing.
191. The Committee agreed that the Guidelines on Good Practice in Pesticide Residue Analysis should be amended to insert in the main body of the text a short statement (to be developed) on the basic principles for the estimation of uncertainty of analytical results and to attach the detailed guidelines as an Annex to the Guidelines.
192. The Committee agreed to circulate for comment at Step 3 the Proposed Draft Guidelines on the Estimation of Uncertainty of Results as contained in Appendix VIII as an amendment to the Guidelines on Good Practice in Pesticide Residue Analysis.
193. The Committee also agreed that the Delegation of the Netherlands would prepare a paper considering the issues related to the use and implications of measurement uncertainty, with the assistance of interested delegations, for consideration at the next session.
(C) PROPOSED DRAFT REVISION OF THE LIST OF METHODS OF ANALYSIS FOR PESTICIDE RESIDUES AT STEP 4
194. The Committee recalled that its last session had agreed that a list of analytical methods would be prepared and circulated for comments and that the current list would be placed on the FAO/IAEA website. However this had not been possible for technical reasons and document CX/PR 04/9 had not been prepared. The Committee was informed that some countries had submitted updated methods in recent years and that the available methods covered the determination of most compounds for which MRLs had been established by Codex. The Committee noted that methods should be submitted either to the delegation of the Netherlands or to the Joint FAO/IAEA Division, and that a template would be prepared by FAO/IAEA to facilitate collection of methods. The Committee agreed to invite FAO/IAEA to put the list of available methods on their website in order to facilitate the update of the list of methods.
195. The Committee welcomed the offer of the Delegation of the Netherlands to collate the available methods and to report to the next session.
196. The Committee noted that the Working Group had discussed the problems related to the determination of dithiocarbamates in capers, as this plant belongs to the Brassica family and naturally produces compounds that release CS2 under acid-hydrolysis conditions, which result in anomalous results for dithiocarbamates.
197. The Committee had an extensive discussion on this question. The Delegation of Morocco indicated that analysis of capers using the screening method (CS2 analysis) resulted in seemingly very high levels of dithiocarbamates being detected, although individual dithiocarbamates were not confirmed by HPLC analysis. The Delegation pointed out that in practice this resulted in substantial problems for exporting countries of capers and therefore proposed to include a footnote in the MRL for dithiocarbamates to address this issue.
198. Some delegations suggested that JMPR be asked to consider alternative method for the determination of dithiocarbamates. However, it was noted that there was no dithiocarbamate MRL for capers and that no residues had been detected using HPLC analysis; therefore the problem was related only to methodology and was not the responsibility of JMPR.
199. The Delegation of Brazil indicated that the problem of anomalous results for dithiocarbamates had also been identified with the analysis of papaya and the Committee noted that this could be considered at the next session on the basis of relevant data.
200. On response to a proposal to ask JMPR to reconsider the residue definition of dithiocarbamates, the Delegation of the United States indicated that the change of the residue definition from CS2 to individual dithiocarbamates would require changes to all relevant MRLs and proposed to consider use of confirmation methods when high levels were detected with the screening method, prior to reporting excedence on MRLs.
201. After some further discussion, the Committee agreed to include the following note to the list of MRLs for dithiocarbamates:
“Some commodities contain natural compounds that generate CS2 “
202. The Committee also agreed that this issue would be referred to the Working Group on Methods of Analysis at the next session.
203. The Committee expressed its appreciation to Dr Van Zoonen and to the Working Group for their excellent work and substantial progress on several complex issues and agreed that the Working Group should be re-convened during the next session.
ESTABLISHMENT OF CODEX PRIORITY LISTS OF PESTICIDES (Agenda Item 10)16
204. The report of the ad hoc Working Group on Priorities was presented by its Chair, Dr Trevor Doust (Australia) who highlighted the main issues discussed and the amendments proposed to the tentative lists of scheduled compounds.
205. The Committee agreed with the proposals of the Working Group and amended the schedule as follows:
2004: Dithiocarbamates (105) was removed because the revised JMPR data requirements meant that additional environmental studies were no longer required.
2005: Sulfuryl fluoride was tentatively scheduled for both toxicological and residues evaluation in 2005, instead of 2007, taking into account that is a replacement for methyl bromide.
2006: Propiconazole (160) was moved from 2007 to 2006 for periodic residue re-evaluation.
2007: Lambda-cyhalothrin was reinstated in the tentative schedule for toxicological re-evaluation in 2007.
2011/2013: Dichlorvos (025) and fenpropathrin (185) were tentatively scheduled for toxicological re-evaluation in 2011 and for residues in 2013.
Bromopropylate (070) has not been supported for evaluation and therefore was deleted from schedule.
206. In addition, it was agreed to include zeta-cypermethrin in the tentative schedule for a complete toxicological re-evaluation of cypermethrin in 2006, as the periodic evaluation of of alpha- and zeta- cypermethrin for residues was scheduled for 2005.
207. The Committee noted that in the framework of the FAO/WHO/OECD Pilot Project on Worksharing, to asses the feasibility of using national evaluations as part of the JMPR assessment, JMPR would evaluate trifloxystrobin in 2004 and that work on another chemical could be initiated in 2006. The Observer from Croplife International indicated that bifenazate, dimethomorph and quinoxyfen could be considered as candidate compounds. The WHO Representative pointed out that is was necessary to coordinate the schedules of evaluations between JMPR and regional or national authorities. The Committee welcomed the offer from the European Community to provide a list of compounds for which evaluations are available to the JMPR Secretariat.
208. The Committee noted the difficulties faced by the WHO Joint Secretary in the preparation of the agenda for the WHO JMPR due to the delays in the submission of data for review and agreed to ask for better commitment from data submitters. The Observer of Croplife International advised the Committee that data availability still needed to be confirmed for benalaxyl (155), cyhexatin (067)/azocyclotin(129), chlorpropham(201), ethoxyquin(35), guazatine(114), and imazalil(110) but data for all other compounds scheduled for evaluation by 2005 JMPR would be submitted.
209. FAO indicated financial problems in expanding membership both for FAO and WHO. The Committee noted with satisfaction the proposal to expand the evaluation capacity of the JMPR by 2007, as presented by the FAO Joint Secretary and supported the strengthening of JMPR.
210. The WHO Joint Secretary referred to the financial difficulties faced by WHO to carry out JMPR evaluations and invited delegations to draw the attention of their governments to the need to support WHO in this area.
PROPOSED DRAFT CRITERIA FOR PRIORITIZATION PROCESS OF PESTICIDES (Agenda Item 10a17)
211. The Committee recalled that its last session had considered a set of criteria for the prioritization of pesticides and had agreed to circulate them for comments and consideration at its next session. The Committee noted that the Working Group on Priorities had proposed some amendments to the criteria included in document CX/PR 04/11 (section 2.3 Evaluation) in order to minimize confusion in data submission process.
212. The Committee had a general discussion on the document in particular on section 2,3.
213. The Delegation of Japan, while supporting the establishment of prioritization criteria, questioned some of the proposed procedures that appeared to deviate from the Codex procedure and stated that the text did not differentiate between Codex and JMPR procedures.
214. The Delegation of the EC expressed its concern that the criteria document implies that industry could propose the development of new or revised MRLs and recalled that such proposals could only be made by members of the Commission.
215. The Codex Secretariat recalled that the criteria for prioritization of pesticides should be consistent with the Criteria for the Establishment of Work Priorities, especially if they were intended for inclusion in the Procedural Manual; that in the framework of Codex only governments could make proposals for new work and that no reference could be included to proposals from the industry.
216. The JMPR Secretariat informed the Committee that governments or industry could make proposals for evaluation and could submit data directly to JMPR, and that this highlighted the differences between the procedures followed by JMPR and by Codex.
217. The Delegation of Australia pointed out that the participation of the industry was essential, as the manufacturers provide the data to JMPR, and suggested the text be made more general and suggested to clarify the data requirements and procedures for various scenarios under the evaluation category.
218. The Codex Secretariat and the JMPR Secretariat proposed to separate clearly the criteria from the procedures in the document in order to avoid confusion; and to separate the provisions that were applicable to Codex from those applicable to JMPR. It was also noted that provisions concerning data submission could be replaced by a reference to the relevant recommendations from FAO and WHO in this respect.
219. The Committee recognized that it would not be possible to finalize the text at the current session and agreed to circulate the revised version of the Proposed Draft Criteria, as contained in Appendix X for comments and consideration at the next session and agreed that the Working Group should be reconvened prior to the next Session of the Committee.
DISCUSSION PAPER ON THE PILOT PROJECT FOR THE EXAMINATION OF NATIONAL MRLS AS INTERIM CODEX MRLS FOR SAFER REPLACEMENT PESTICIDES (Agenda Item 11)18
220. The Committee recalled that at its last Session, it had agreed to initiate the pilot project and that the 26th Session of the Commission approved work on the project with the understanding that the Proposed Interim MRLs would be submitted for adoption at Step 8 by the Commission.
221. The Delegation of the United States introduced the document and indicated that issues and concerns expressed by the delegations at the last session of the Committee had been addressed during the revision of the document. The Delegation clarified that chemicals proposed and accepted for the Pilot Project must meet the criteria of being new, safer, and replacement chemicals as described in CX/PR 03/14 and that the current document included indicators on how success of the pilot project would be measured. The paper also outlined the procedure that would allow member countries to assess the nominations and conduct a scientific review that should lead to consensus-based MRL recommendations. It was indicated that there was consistency with the normal Codex MRL setting process; and that the interim MRL procedure would allow the faster establishment of MRLs for safer compounds in Codex which would facilitate use of safer pesticides. The Delegation outlined the steps and procedures for the establishment of interim MRLs (as presented in CRD 21) and pointed out that the first two steps had been completed: bifenazate, fludioxonil and trifloxystrobin had been nominated and an executive summary of the supporting information had been provided to the Working Group on Priorities.
222. The Delegation indicated that the detailed summary containing the information necessary to evaluate compounds would be provided to member governments in sufficient time for them to evaluate the information and submit their comments and that if a member government requests a specific study report(s) as critical part of their review of the nomination, such requests would be addressed by the nominating country.
223. In order to assist in the validation of the proposed interim MRL procedure, and noting that fludioxonil and trifloxystrobin were scheduled for JMPR 2004 evaluation, the Delegation suggested that JMPR be asked to compare their recommendations with the proposed interim MRLs and to comment on discrepancies.
224. The Delegation suggested that the 37th session of the CCPR consider recommendations of the Priorities Working Group and comments. It might then decide to advance the proposed MRLs to the Commission for interim adoption or proposes to delete them. The Committee would also decide on possible revision/improvement of the process for elaborating interim MRLs.
225. Many delegations supported the proposed pilot project in principle and indicated that the establishment of interim MRLs would introduce safer pesticides, facilitate trade and improve efficiency of Codex.
226. Some delegations commented on the definition of “safer” and “replacement” compounds, the need to clarify the roles and responsibilities of the different parties, the importance of accessibility to the raw data and how decisions would be taken if different MRLs were proposed by different countries for the same commodity.
227. Some delegations pointed out that the implementation of the interim MRL procedure should not detract from the need to reinforce the work of JMPR and expressed concern that the procedure could result in an incomplete separation of risk assessment and risk management. The Delegation of the United States clarified that while structurally the risk assessment and risk management in the proposed procedure are both under the CCPR, in fact, the risk assessments would be carried out by national governments with risk management decisions taken by CCPR.
228. Some delegations expressed concern regarding the availability of the complete national government assessments for chemicals including toxicology and residue reviews. It was clarified that the process was meant to include the assessments from the national governments that had established the MRLs being proposed and that the government of the nominating country would obtain these assessments when working with data submitters. It was noted that one national government assessment for each MRL would be sufficient and that if more than one MRL was proposed for a commodity, the highest MRL would be considered.
229. Many delegations supported a thorough evaluation of the project before deciding on whether to nominate a further group of substances and that Interim MRLs should be approved for a limited four year period of time. It was also proposed to limit the pilot project to compounds that are scheduled for evaluation by JMPR within four years and to consider refining the procedure in future meetings of the Committee.
230. The Delegation of the United States agreed that the evaluation of the process of the pilot project was of great importance and was of the view that this evaluation would depend on member governments and JMPR feedback. The Delegation suggested that the originally established Pilot Project Working Group19 could consider comments from member governments and JMPR on the operation of the procedure and prepare a paper on the proposed procedure for consideration.
231. The Committee concluded that some uncertainties existed with some of the procedures involved in the Pilot Project but recognized that these uncertainties should be able to be resolved during the pilot phase of the project. The Committee agreed to use the procedure for establishment of interim MRLs as described in CRD 21 and that Interim MRLs established under the scheme should be maintained not more than four years.
232. The Committee noted that Member Organizations could also nominate chemicals and propose interim MRLs.
233. In clarifying the procedure to be followed, the Committee confirmed that:
• detailed summaries of evaluations would be circulated for comments to Members by the Codex secretariat upon submission by nominating country
• comments from Members would be compiled by the Pilot Project Working Group and sent to the Working Group on Priorities and to Members and other interested parties
• the Working Group on Priorities would address technical issues and provide recommendations for the next session of the Committee
234. The Committee also agreed that the Pilot Project Working Group would prepare draft proposals on refinements of the procedure, based on comments received for consideration by the next session of the Committee.
CONSIDERATION OF THE ELABORATION OF MRLS FOR SPICES (Agenda Item 12)20
235. The Committee noted that following the decision of the 35th Session of the Committee the Delegation of South Africa and its drafting partners had prepared a revised paper to provide further information on the elaboration of MRLs for spices.
236. The Delegation of South Africa introduced the paper and informed the Committee that the revised paper clarified the definition of spices and provided the list of spices of interest, irrespective of whether they were classified as spices in the Codex Classification; proposed grouping of similar spices for purposes of elaboration of group MRLs; considered existing MRLs on fresh vegetables, the dried form of which are also used as spices; and clarified the criteria for use of monitoring data to set MRLs for pesticides on spices.
237. Several delegations welcomed the paper and supported its content, especially as the proposals in the paper would facilitate the elaboration of MRLs for commodities of importance for developing countries.
238. The Delegation of the EC, in addition to its written comments, indicated that Codex MRLs should normally be established following the existing procedures and that only in exceptional cases where the concerned commodity such as spices forms a very minor component of diet, monitoring data could be used to elaborate MRLs.
239. The Committee amended the definition of spices as suggested by India by including “rhizome” and “flowers and parts thereof”, in order to be consistent with groupings of spices.
240. The Committee noted that saffron was also produced in several other countries and added Iran, Spain and Malta to the list of saffron producing countries.
241. Noting that MRLs existed for fresh chilli and other peppers for a number of pesticides and that GAP and trial data were required to establish these MRLs, the Committee agreed that chili pepper fell outside of the definition of spices for the proposes of setting MRLs.
242. There was some support for use of the general dehydration factor to derive to MRLs for dried chili peppers and vegetables when they were used as spices.
243. The Committee agreed to include candlenut (Aleyrites moluccana) under the “fruit or berries” group as proposed by the Delegation of Indonesia.
244. The Delegation of China reiterated the suggestion to use monitoring data to establish MRLs for tea. However, it was clarified that Codex MRLs for tea existed and that a decision had already been taken to limit the use of monitoring data for to establish MRLs for spices.
245. The Delegation of Thailand suggested that after gaining more experience on the elaboration MRLs for spices it could be possible to extend this approach to herbs.
246. The Committee agreed with the following recommendations as proposed in the document:
§ To request JMPR to review existing MRLs on peppers with the view of setting MRLs for dried chilli peppers using processing/dehydration factors as appropriate. The industry is encouraged to submit to the JMPR any processing study that would support the derivation of such dehydration factor(s).
§ To schedule for JMPR review, the elaboration of MRLs on spices in Group 028 as modified, for pesticides already in the Codex system for which the data must be submitted by the first week of May 2004;
§ To ask governments, spice trade industry, and interested parties to organize the monitoring data on spices according to the format prescribed by the JMPR and to send the data to South Africa who will then collate the information and submit the consolidated data to JMPR as soon as the schedule for evaluation has been set; and
§ To consider the inclusion of spices among the commodities for which MRLs should be established, whenever a pesticide is evaluated under the periodic review process, if the pesticide is one of those observed on spices in the monitoring process;
247. The Committee also recommended that governments and the spice trade industry continue to collect monitoring data for pesticides on spices on a regular basis, following agreed criteria and other JMPR guidelines on the conduct of selective surveys, in order to keep the database updated for future review.
DISCUSSION PAPER ON THE REVISION OF THE CODEX CLASSIFICATION OF FOODS AND ANIMAL FEEDS (Agenda Item 13)21
248. The Committee noted that the review of the Codex Classification of Foods and Animal Feeds had been considered at the last session and that there was general support for the limited revision.
249. The Delegation of the Netherlands introduced the document and indicated that the electronic form (MS Word) of the Classification provided by the Delegation of Australia could be used as a basis for the proposed revision which is placed on FAO website.
250. It was indicated that the Delegation of the USA has made available a Microsoft Access database on the internet, which also could be used as a basis for proposed revision. The Delegation was of the view that while in principle both systems could be used for the revision, the MS-Word version should be used initially.
251. The Delegation indicated that new commodities proposed by governments were listed in Appendix 1 and that this list, together with those commodities suggested by Delegation of Malaysia (CRD 17) should be evaluated against criteria proposed in the document. The attention of the Committee was also drawn to the fact that several governments had made proposals to subgroup and regroup commodity groups (included in Appendix 2 and in CRD 17), and that proposals for regrouping of individual commodities, updating of scientific names and expansion of codes with new varieties or species were listed in Appendix 3.
252. The Delegation informed the Committee that several countries had proposed the inclusion of other commodity groups and suggested that such proposals should be evaluated for their importance and that governments proposing the inclusion of new commodities should be asked to provide information on the importance of the commodity in international trade, in the diet or for setting MRLs. The Delegation suggested that governments be asked to comment on the current proposals, to submit new proposals for commodities not included in the Classification.
253. The Committee noted the need to assign code letters and code numbers to the uncoded commodities for MRLs for which JMPR had proposed carbaryl and methomyl.
254. The Secretariat informed the Committee that the CCFAC had asked the CCPR to consider the possibility of work on common classification.
255. The Delegation of Japan indicated that the request of the CCFAC related to their work on the establishment of maximum levels for contaminants, and that the questions of processed foods should be considered jointly to achieve consistency between the two Committees.
256. The Delegation of Australia commented that the proposed revision had been discussed by the Committee for quite some time and that there was a need to proceed with the revision without further delay.
257. The Committee agreed to ask the Commission to approve new work on the limited revision of the Classification. The Committee agreed to attach the Appendices of the document CX/PR 04/14 to the report and to invite additional comments on the above proposals (see Appendix IX).
258. The Committee requested the Delegation of the Netherlands with assistance of the Delegation of Japan to prepare a revised version of the Classification for circulation at Step 3 and consideration at its next session and requested the above delegations to prepare a project document for new work (see para 8).
DISCUSSION PAPER ON THE ESTABLISHMENT OF MRLs FOR PROCESSED OR READY-TO-EAT FOODS (Agenda Item 14)22
259. The Committee recalled that its last session had asked the Delegation of the United States, with the assistance of the Delegation of the Netherlands, to prepare a discussion paper on the policy to be followed in the establishment of MRLs for processed foods.
260. The Delegation of the United States informed the Committee that the paper had not been prepared as the Committee needed to decide first whether the current policy on the establishment of MRLs for processed foods should be followed or whether more fundamental changes were required. The Delegation supported the current approach of JMPR, as reflected in section 2.7 of the JMPR 2003 Report.
261. The Delegation of the EC indicated that in the EC MRLs are set for raw commodities and then applied to processed and composite foods after applying the appropriate processing or percentage composition factors. The Delegation pointed out that this was an important subject that required further discussion and proposed to develop guidelines in this area.
262. The Committee welcomed the proposal of the Delegation of the EC with the assistance of the Delegation of the United States to prepare a discussion paper on the use of processing studies and the establishment of MRLs for processed foods for consideration at the next session.
OTHER BUSINESS AND FUTURE WORK (Agenda Item 15)23
263. The Delegation of India indicated that it had generated national residue trial data for the establishment of MRLs for a number of compounds in tea and seed oils and asked whether these data could be considered by JMPR. The Delegation of China informed the Committee that they would also submit data after compilation to support MRLs for tea. The JMPR Secretariat noted that although the deadline for data submission for JMPR 2004 was already passed, it would be possible to consider additional data for paraquat if India submitted the data in the JMPR format as soon as possible, and that for other compounds requests for data evaluation should be forwarded to the Priorities Working Group. Consumers International generally supported this proposal,
264. The Delegation of Mexico asked for clarification on the entry into force of Codex adoption or revocation of MRLs and how this would affect the use of compounds at the national level. The Secretariat indicated that Codex MRLs, standards and related texts were recommendations to governments and a reference in international trade while the establishment of regulations on MRLs at the national level was the responsibility of member countries.
265. The Delegation of the EC informed the Committee that the WTO SPS Agreement included provisions to address this problem.
DATE AND PLACE OF THE NEXT SESSION (Agenda Item 15)
266. The Committee was informed that the 37th Session would be held in The Hague from 18 to 23 April 2005.
267. The Committee welcomed the offer from the Delegation of Brazil to hold the 38th Session in Brazil in 2006.
Annex 1
SUMMARY STATUS OF WORK
Subject |
Step |
Action by |
Document Reference |
Draft and Revised Draft MRL s |
8 |
Governments, 27th Session of the CAC |
Paras 60-175 and Appendix II |
Draft and Revised Draft MRLs |
5/8 |
Governments, 27th Session of the CAC |
Paras 60 – 175 and Appendix III |
Proposed Draft MRLs |
5 |
Governments, 27th Session of the CAC |
Paras 60-175 |
Codex Maximum Residue Limits Recommended for Revocation |
Paras 60-175 | ||
Draft and Proposed Draft MRLs |
6 / 3 |
Governments, CCPR 37 |
Paras 60-175 and Appendix VI |
Proposed Draft and Revised Draft Maximum Residue Limits for Pesticides (Retained at Step 7 and 4) |
Paras 60-175 and Appendix XII | ||
Proposed Draft Revision of the List of Methods of Analysis for Pesticide Residues |
3 |
FAO/IAEA, Governments, 37th CCPR |
Para. 194 |
Proposed Draft Guidelines on the Use of Mass Spectrometry (MS) for Identification, Confirmation and Quantitative Determination of Residues |
3 |
Governments, 37th CCPR |
Para. 189 Appendix VII |
Proposed Draft Guidelines on the Estimation of Uncertainty of Results |
3 |
Governments, 37th CCPR |
Para. 192 and Appendix VIII |
Proposed Draft Criteria for Prioritization Process of Pesticides |
Governments, 37th CCPR |
Para. 219 and Appendix X | |
New work: |
|||
Priority List of Pesticides (New Pesticides and Pesticides under Periodic Review) |
1 |
27th Session of the CAC, Governments, Australia, 37th CCPR |
Paras 204-206 and Appendix XI |
Limited Revision of the Codex Classification of Foods and Animal Feeds |
1/2/3 |
27th Session of the CAC, Netherlands, Governments, 37th CCPR |
Para. 257 and Appendix IX |
Discussion papers on: |
|||
Risk Analysis Policies Used in Establishing Codex MRLs |
Chairperson, 37th CCPR |
Para. 144 | |
Use and Implications of Measurement Uncertainty |
Netherlands |
Para. 193 | |
Draft Proposals on Refinements of the Codex Interim MRLs Establishment Procedure |
US24, Governments, 37th CCPR |
Para. 234 | |
Establishment of MRLs for Processed or Ready-to-Eat Foods |
EC, USA, 37th CCPR |
Para. 262 | |
1 For proposed draft MRLs to be proposed by the JMPR 2004 (20 - 29 September 2004) a separate CL will be issued.
2 In completing Appendix II, only a brief outline is needed. The form may be retyped if more space is needed under any one heading provided that the general format is maintained.
While consulting Appendix I, please note that pesticide/commodity combinations which are already included in the Codex system or under consideration are found in a working document prepared for and used as a basis of discussion at each Session of the Codex Committee on Pesticide Residues; the most recent being CX/PR 04/5. Consult the document to see whether or not a given pesticide has already been considered.
3 CX 04/2; CX/PR 04-Add.1; CRD 3 (Report of the FAO/WHO Workshop on the Provision of Scientific Advice to Codex and Member Countries); CRD 10 (comments from the European Community).
4 Report of the 2003 JMPR; CRD 9 (Comments of the EC), CRD 10 (comments of the EC); CRD 15 (comments of Consumers International).
5 Report of the FAO/WHO Workshop on the Provision of scientific advice to Codex and Member Countries
6 National Institute for Public Health and the Environment (RIVM); Centre for Substances and Integrated Risk Assessment (SIR)
7 Hamilton D, Ambrus A, Dieterle R, Felsot A, Harris C, Petersen B, Racke K, Wong S, Gonzalez R, Tanaka K, Earl M, Roberts G and Bhula, R. 2003. Pesticide residues in food – acute dietary exposure. .(CRD 7)
8 WHO, Food consumption and exposure assessment of chemicals. Report of a FAO/WHO Consultation, Geneva, Switzerland, 10-14 Feb, 1997. Document WHO/FSF/FOS/97.5 (1997)
9 Hamilton D, Ambrus A, Dieterle R, Felsot A, Harris C, Petersen B, Racke K, Wong S, Gonzalez R, Tanaka K, Earl M, Roberts G and Bhula, R. 2003. Pesticide residues in food – acute dietary exposure. Submitted for publication.
10 CX/PR 04/6, CRD 9 (comments of the European Community), CRD 15 (comments of Consumers International )
11 CX/PR 04/4; CRD 2 (Report on the Probabilistic intake calculations performed for the Codex Committee on Pesticide residues, Institute of Food Safety, Wageningen, January 2004); CRD 8 (comments of Crop Life International); CRD 9 (comments of European Community); CRD 14 (comments of Australia); CRD 15 (comments of Consumers International); CRD 24 Additional comments of the European Community); CRD 25 (Report of the Ad Hoc Working Group).
12 Netherlands (Chair), Australia, Denmark, European Commission, Germany, Ireland, Japan, New Zealand, United States of America, FAO, WHO, Crop Life International and International Banana Association.
13 CL 2003/15-PR; CL 2003/26-PR; CX/PR 04/5; CX/PR 04/5-Add.19comments of Australia,EC, USA); CRD 10 (Additional comments of the EC); CRD 15 (comments of Consumers International); CRD 19 (comments of Canada); CRD 20 (comments of Morocco); CRD 22 (English summary of comments of Morocco).
14 CX/PR 04/6, CRD 9 (comments of the European Community), CRD 13 (comments of Japan), CRD 15 (comments of Consumers International )
15 CX/PR 04/7, CRD 5 (Report of the ad hoc Working Group on Methods of Analysis), CRD 22 (comments of Morocco), CRD 24 (comments of the EC)
16 CL 2003/15-PR, ALINORM 03/24, Appendix VIII, CX/PR 04/10, CRD 1 (Report of the ad hoc Working Group on Priorities), CRD 9 (Comments of EC), CRD 10 (Comments of EC).
17 ALINORM 03/24A, Appendix IX; CX/PR 04/11,; CRD 1 (Report of the ad hoc Working Group on Priorities); CRD 6 (comments of the United States); CRD 9 (comments of the European Community).
18 CX/PR 04/12, CRD 4 (Pilot project on the Interim MRL: Study summaries and dietary intake calculations for bifenazate, fludioxonil and trifloxystrobin); CRD 9 (comments of the EC); CRD 15 (comments of Consumers International); CRD 23 (comments of India); CRD 21 (Pilot project on the Interim MRL: Study summaries and dietary intake calculations for bifenazate, fludioxonil and trifloxystrobin; replaces CRD 4); CRD 24 (comments of the EC) and CRD 27 (prepared by the United States).
19 Consisting of Argentina, Australia, Canada, Chile, EC, Egypt, France, The Netherlands, New Zealand, Senegal, South Africa, Sudan, Crop Life International, Consumers International and FAO/WHO Secretariat.
20 CX/PR 04/13; CRD 9 (comments of the European Community); CRD 12 (comments from Indonesia); CRD 26 (corrected table of spices).
21 CX/PR 04/14; CRD 9 (comments of the EC); CRD 17 (comments of Malaysia).
22 CRD 24 (comments of the EC)
23 CRD 28 (comments of India)
24 Argentina, Australia, Canada, Chile, EC, Egypt, France, The Netherlands, New Zealand, Senegal, South Africa, Sudan, FAO/WHO Secretariat, Consumers International and Crop Life International.